Surgical articles and methods for treating pelvic conditions

ABSTRACT

Described are pelvic implants (e.g., urinary incontinence sling, hammock, etc.) and method of inserting a pelvic implant that provide treatment for pelvic floor disorders such as incontinence or stress urinary incontinence.

PRIORITY CLAIM

This application is a continuation of U.S. application Ser. No.12/223,846, filed Jun. 7, 2010, which claims the benefit fromInternational No. PCT/US2007/004015, which was granted an Internationalfiling date of Feb. 16, 2007, which in turn claims priority under 35 USC§ 119(e) from U.S. Provisional Patent Application having Ser. No.60/775,039, filed on Feb. 16, 2006, by Lund et al., titled SINGLEINCISION SLING AND METHOD OF IMPLANTING SAME IN PATIENT; U.S.Provisional Patent Application Ser. No. 60/804,353, filed Jun. 9, 2006,by Westrum et al., titled SURGICAL ARTICLES AND METHODS FOR ADDRESSINGURINARY INCONTINENCE; U.S. Provisional Patent Application having Ser.No. 60/806,073, filed Jun. 28, 2006, by Anderson et al., titled SURGICALARTICLES AND METHODS FOR ADDRESSING URINARY INCONTINENCE; and U.S.Provisional Patent Application Ser. No. 60/805,040, filed Jun. 16, 2006,by Montpetit et al., titled PELVIC FLOOR REPAIR TISSUE FIXATION, whichapplications are incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The invention relates to apparatus and methods for treating pelvicconditions by use of a pelvic implant to support pelvic tissue. Thepelvic conditions include conditions of the female or male anatomy, andspecifically include treatments of female or male urinary and fecalincontinence, and treatment of female vaginal prolapse conditionsincluding enterocele, rectocele, cystocele, vault prolapse, and any ofthese conditions in combination. In particular, the present inventionrelates to a surgically implanted implants that support pelvic tissueand that are secured to pelvic tissue to provide that support.

BACKGROUND

Pelvic health for men and women is a medical area of increasingimportance, at least in part due to an aging population. Examples ofcommon pelvic ailments include incontinence (fecal and urinary) andpelvic tissue prolapse (e.g., female vaginal prolapse). Urinaryincontinence can further be classified as including different types,such as stress urinary incontinence (SUI), urge urinary incontinence,mixed urinary incontinence, among others. Other pelvic floor disordersinclude cystocele, rectocele, enterocele, and prolapse such as anal,uterine and vaginal vault prolapse. A cystocele is a hernia of thebladder, usually into the vagina and introitus. Pelvic disorders such asthese can result from weakness or damage to normal pelvic supportsystems.

In its severest forms, vaginal vault prolapse can result in thedistension of the vaginal apex outside of the vagina. An enterocele is avaginal hernia in which the peritoneal sac containing a portion of thesmall bowel extends into the rectovaginal space. Vaginal vault prolapseand enterocele represent challenging forms of pelvic disorders forsurgeons. These procedures often involve lengthy surgical proceduretimes.

Urinary incontinence can be characterized by the loss or diminution inthe ability to maintain the urethral sphincter closed as the bladderfills with urine. Male or female stress urinary incontinence (SUI)occurs when the patient is physically stressed.

One cause of urinary incontinence is damage to the urethral sphincter.Other causes include the loss of support of the urethral sphincter, suchas can occur in males after prostatectomy or following radiationtreatment, or that can occur due to pelvic accidents and aging relateddeterioration of muscle and connective tissue supporting the urethra.Other causes of male incontinence include bladder instability,over-flowing incontinence, and fistulas.

The female's natural support system for the urethra is a hammock-likesupportive layer composed of endopelvic fascia, the anterior vaginalwall, and the arcus tendineus. Weakening and elongation of thepubourethral ligaments and the arcus tendineus fascia pelvis, andweakening of the endopelvic fascia and pubourethral prolapse of theanterior vaginal wall, may have a role in the loss of pelvic support forthe urethra and a low non-anatomic position that leads to urinaryincontinence.

In general, urinary continence is considered to be a function ofurethral support and coaptation. For coaptation to successfully preventor cure incontinence, the urethra must be supported and stabilized inits normal anatomic position. A number of surgical procedures andimplantable medical devices have been developed over the years toprovide urethral support and restore coaptation. Examples of suchsurgical instruments included Stamey needles, Raz needles, and Pereyraneedles. See Stamey, Endoscopic Suspension of the Vesical Neck forUrinary Incontinence in Females, Ann. Surgery, pp. 465-471, October1980; and Pereyra, A Simplified Surgical Procedure for the Correction ofStress Incontinence in Women, West. J. Surg., Obstetrics & Gynecology,pp. 243-246, July-August 1959.

One alternative surgical procedure is a pubovaginal sling procedure. Apubovaginal sling procedure is a surgical method involving the placementof a sling to stabilize or support the bladder neck or urethra. Thereare a variety of different sling procedures. Descriptions of differentsling procedures are found in U.S. Pat. Nos. 5,112,344, 5,611,515,5,842,478, 5,860,425, 5,899,909, 6,039,686, 6,042,534, and 6,110,101.

Some pubovaginal sling procedures extend a sling from the rectus fasciain the abdominal region to a position below the urethra and back again.The slings comprise a central portion that is adapted to support theurethra or a pelvic organ (i.e., a “support portion” or “tissue supportportion”), and two extension portions bracketing the support portion,optionally a protective sheath or sheaths encasing at least theextension portions. Although complications associated with slingprocedures are infrequent, they do occur. Complications include urethralobstruction, prolonged urinary retention, bladder perforations, damageto surrounding tissue, and sling erosion.

Other treatments involve implantation of a Kaufman Prosthesis, anartificial sphincter (such as the AMS-800 Urinary Control Systemavailable from American Medical Systems, Inc.), or a urethral slingprocedure in which a urethral sling is inserted beneath the urethra andadvanced to the retropubic space. Peripheral or extension portions ofthe elongated urethral sling are affixed to bone or body tissue at ornear the retropubic space. A central support portion of the elongatedurethral sling extends under the urethral or bladder neck to provide aplatform that compresses the urethral sphincter, limits urethraldistention and pelvic drop, and thereby improves coaptation. Similarattached slings or supports have been proposed for restoring properpositioning of pelvic organs, e.g., the vagina or bladder.

Elongated “self-fixating” slings have also been introduced forimplantation in the body, to treat pelvic conditions such as prolapseand incontinence conditions. Self-fixating slings do not require theextension portions to be physically attached to tissue or bone. Rather,the slings rely upon tissue ingrowth into sling pores to stabilize thesling. See, for example, commonly assigned U.S. Pat. Nos. 6,382,214,6,641,524, 6,652,450, and 6,911,003, and publications and patents citedtherein. The implantation of these implants involves the use of rightand left hand sling implantation tools that create transvaginal,transobturator, supra-pubic, or retro-pubic exposures or pathways. Adelivery system for coupling the sling ends to ends of elongateinsertion tools, to draw sling extension portions through tissuepathways, is also included. Needles of the right and left hand insertiontools described in the above-referenced 2005/0043580 patent publicationhave a curvature in a single plane and correspond more generally to theBioArc™ SP and SPARC™ single use sling implantation tools sold in a kitwith an elongated urethral sling by American Medical Systems, Inc.

In some sling implantation kits, the needle portion has a proximalstraight portion extending from the handle and a distal curved portionterminating in a needle end or tip. As described in the above-referenced'003 patent, the kit may include more than one type of implantation tool(also, “insertion tool”). The kit may include one tool suitable for anoutside-in (e.g. from the skin incision toward a vaginal incision)procedure and another that may be suitable for an inside-out (e.g. fromthe vaginal incision toward a skin incision) procedure. Surgeons thatprefer an approach dictated by the surgeon's dominant hand can selectthe procedure and the appropriate implantation tool. Alternately,universal implantation tools (e.g., right and left sling implantationtools each suitable for both an inside-out and an outside-in approach)may be provided.

Optionally, a detachable protective sheath may encase some portion of anextension portion of a pelvic implant. Connectors may be attached to theends of the extension portions for connecting with an end of aninsertion tool. Generally speaking, the insertion tool ends are insertedaxially into the connectors, and the extension portions of the implantare drawn through pathways trailing the connectors and needles to draw acentral support portion against the pelvic tissue (e.g., the urethra) toprovide support. The connectors are drawn out through skin incisions andthe implant and encasing sheath are severed adjacent to the connectors.

Similar transobturator implantation procedures for implanting a pelvicimplant to support a pelvic organ, e.g., the vagina, restored in properanatomic position, are described in commonly assigned U.S. PatentApplication Publication Nos. 2005/0043580 and 2005/0065395. Alternateimplantation procedures for creating tissue pathways exiting the skinlateral to the anus and implanting an implant extending between the skinincisions to support a pelvic organ, e.g., the vagina, restored inproper anatomic position, are described in commonly assigned U.S. PatentApplication Publication No. 2004/0039453 and in PCT Publication No. WO03/096929. Various ways of attaching a sleeve end and implant meshextension to a self-fixating tip are detailed in the above-referenced'450 patent, for example. Further ways of attaching extensions of animplant to an implantation tool are described in U.S. Patent Publication2004/0087970. In each case extra incisions must be made in the patient'sabdomen.

SUMMARY

The present patent application describes pelvic implants and methods fortreating pelvic conditions such as incontinence (various forms such asfecal incontinence, stress urinary incontinence, urge incontinence,mixed incontinence, etc.), vaginal prolapse (including various formssuch as enterocele, cystocele, rectocele, vault prolapse, etc.), amongothers. Embodiments of implants include a self-fixating tip at a distalend of one or more extension portions. The self-fixating tip can beplaced at and secured within internal tissue of the pelvic region tosupport the implant end extension and pelvic tissue that is supported bythe implant. As an example, a self-fixating tip can be placed at tissueof the obturator foramen (this phrase referring to tissue that lieswithin or spans the obturator foramen, for example the obturatorinternus muscle, the obturator membrane, or the obturator externusmuscle). Other tissue of the pelvic region can also be locations usefulfor implanting a self-fixating tip. The self-fixating tips can bedesigned to engage a distal end of an insertion tool to allow theinsertion tool to place the self-fixating tip at a desired tissuelocation by pushing.

Embodiments of self-fixating tips can be designed to provide desiredfunction and performance in becoming positioned and maintaining positionwithin tissue of the pelvic region. For example, a self-fixating tip canbe designed to provide desirably low input force, desirably high pulloutforce, and reduced trauma caused by passage of the self-fixating tip oran associated insertion tool. A self-fixating tip may also be designedto allow for removability in situations of necessity, with reducedtrauma to tissue. The self-fixating tip can be designed to minimizeremoval force and trauma in instances that require removal. Thesefunctional properties can result from selecting size and shape featuresof a self-fixating tip, such as relatively reduced overall dimensions(length or diameter) of the tip; and size, shape, and number of lateralextensions.

Exemplary methods of using a self-fixating tip attached to an implant,when implanted by use of an elongate insertion tool, allow a physicianto obtain direct tactile palpation without relying on visualization ormore exposure to the site. By certain previous procedures for pelvicrepair, for example, a physician may have to make a deep connection oruse retraction to get better exposure to deliver an implant. Pelvicsurgeons inherently rely on tactile feedback and palpation of criticalstructures when placing these implants. The invention can eliminate thedeep connection issues of certain currently-used products and methods,and allow a physician to deliver an implant to the pelvic region withless difficulty and in a manner that can be more natural to theirsurgical techniques.

Potential advantages related to the use of the certain of thecurrently-described methods and devices can include reduced overalltrauma of a procedure due to one or more of: design of a self-fixatingtip or insertion tool; reduced trauma caused by a self-fixating tip orassociated insertion tool, due to a reduced length of tissue passages(e.g., for posterior repairs); reduced trauma based on the ability toavoid tissue passages next to critical structure; and reduced trauma dueto the ability to eliminate the need for local stab (external) incisionsotherwise required for needle entry and exit sites.

According to exemplary methods, a physician identifies tissue within thepelvic region to which a self-fixating tip will be secured. An insertiontool and self-fixating tip can be introduced through a medial incisionto insert a permanent (plastic i.e., polypropylene or metal) orbioresorpable implant assembly that includes a self-fixating tip havingone or multiple lateral extensions, to the target site. This procedurecan be performed by use of a single (medial) incision.

One embodiment of implant is a urinary incontinence sling that includesa sling body, a first self-fixating tip (sometimes alternately referredto herein as an “anchor” or “anchor member”) attached to a first end ofthe sling, and a second anchor member attached to a second end of thesling, wherein the sling is made of a single piece of mesh material.

The invention also contemplates a method of treating urinaryincontinence in male and female patients. The method include creating asingle medial incision (a transvaginal incision or a perineal incision)under the mid-urethra, dissecting a tissue path on each side of theincision, passing a urinary incontinence sling through the incisionwhereby the urinary incontinence sling is suspended between theobturator internus muscles and the sling body is positioned between thepatient's urethra and vaginal wall (for a female) to provide support tothe urethra. For males, a perineal incision can be made to pass thesling through the incision and suspend the sling in a manner comparableto the sling installed in the female patient anatomy. A procedure fortreating male urinary incontinence may be performed with or following aprostatectomy, or otherwise.

In addition to treating urinary incontinence, the invention alsocontemplates methods relating to other types of pelvic floor repairs.Currently, pelvic floor repairs are surgically treated through graftaugmented repairs and with kit systems that use needles to deliver agraft through an incision on the anterior and posterior vaginal wall.These current procedures address tissue, muscle and ligament weakness inthe pelvic floor such as rectoceles, enteroceles, cystoceles, apical,and uterine descent.

The invention allows pelvic floor reconstruction procedures to becomemore minimally invasive and easier to use for all pelvic floor surgeongroups. The invention relates to a tissue fixation anchoring system thatcan be applied to a variety of areas of the pelvic floor: anteriorrepairs, posterior repairs, apical support, perineal body support(address levator hiatus openings), fecal incontinence, hysterectomyrepairs with vault support by means of graft augmentation with tissueanchors into several different anatomical landmarks. These landmarks maybe the white line, muscle, and fascial layers, ligament structures(sacrospinous, sacrotuberous, cardinal, round, uterosacrals, perinealand rectal ligaments, etc.) etc. The self-fixating tip can be deliveredto tissue in combination with a sling, hammock, or suture thread,introduced with an elongate insertion tool directly to tissue.

Another embodiment is a method of treating urinary incontinence (e.g.SUI) in a minimally invasive manner including injecting a localanesthetic; creating only one medial (e.g., transvaginal) incision underthe mid-urethra; providing a urinary incontinence sling, the slingincluding a sling body and a first and second anchors operably attachedto the sling body; inserting the first anchor through the incision andsecuring the anchor into a desired location in the pelvic region;inserting the second anchor through the incision and anchoring thesecond anchor at a desired location in the pelvic region; positioningthe sling into a desired supporting position relative to the urethra;and closing the incision. Advantageously, the entire procedure can beperformed with a single incision, e.g., the transvaginal incision. Thereis no need for any external incision of the patient such as with othermethods of installing a urethral sling.

Yet another embodiment is method of treating female urinary incontinence(e.g., SUI) in a minimally invasive manner that includes injecting alocal anesthetic, creating only one transvaginal incision under themid-urethra, inserting a urinary incontinence sling through the onetransvaginal incision, anchoring the urinary incontinence sling, andclosing the incision.

The present invention furthermore includes a method and apparatus for aurinary incontinence sling that is implanted through a single vaginal(or perineal for males) incision whereby the sling does not exit throughanother skin incision such as an abdominal or leg incision.

An aspect of the invention relates to a pelvic implant assembly thatincludes a support portion and an extension portion, and a self-fixatingtip connected to the extension portion. The self-fixating tip includes abase comprising a proximal base end and a distal base end, the proximalbase end being connected to the extension portion. The base includes aninternal channel extending from the proximal base end at least partiallyalong a length of the base toward the distal base end. The self-fixatingtip further includes a fixed lateral extension extending from the base.

In another aspect, the invention relates to a pelvic implant assemblythat includes a support portion and an extension portion, with aself-fixating tip connected to the extension portion. The self-fixatingtip includes a base comprising proximal base end and a distal base end,the proximal base end being connected to the extension portion distalend. The self-fixating tip also includes a fixed lateral extensionextending from the base. The lateral extension includes a lateralextension body bounded by edges or boundaries that include a leadingedge, a trailing edge, and a length at which the lateral extension meetsthe base. The trailing edge has a thickness greater than the leadingedge.

Another aspect of the invention includes a combination (e.g., kit,system, etc.) of an implant, as described herein, including one or moreself-fixating tip. The kit also includes one or more insertion tooluseful with the implant.

In another aspect, the invention relates to a method of treating apelvic condition. The method includes providing an implant according tothe current description; providing an insertion tool that includes ahandle and a needle extending from the handle, the needle including aproximal end attached to the handle and a distal end, the distal endincluding a needle distal end that removably engages the self-fixatingtip; engaging the needle distal end with the self-fixating tip,inserting the needle distal end and tip through an incision in apatient; and inserting the self-fixating tip into tissue in the pelvicregion.

In another aspect the invention relates to a method of treating a pelviccondition. The method includes creating a single incision through thevagina or perineal floor; dissecting tissue beneath tissue to besupported; providing a pelvic implant according to the presentdescription; passing the pelvic implant through the incision; andimplanting the self-fixating tip at tissue of the pelvic region.

Yet another aspect of the invention relates to a method of treating apelvic condition. The method includes: creating only one incision underthe mid-urethra through the vagina or through the perineal floor;providing an implant according to the present description; inserting aself-fixating tip through the incision and anchoring the self-fixatingtip within fibrous tissue; inserting a second self-fixating tip throughthe incision and anchoring the self-fixating tip within fibrous tissue;positioning the implant into a desired supporting position relative totissue of the pelvic region; and closing the incision.

BRIEF DESCRIPTION OF DRAWINGS

Other features and advantages of the present invention will be seen asthe following description of particular embodiments progresses inconjunction with the drawings. Drawings are schematic and not to scale.

FIG. 1 illustrates a side view of an embodiment of a self-fixating tip.

FIG. 2 illustrates an end view of an embodiment of a self-fixating tip.

FIG. 3A illustrates an embodiment of a kit according to the invention,the kit including an implant and an insertion tool.

FIG. 3B illustrates an embodiment of an implant according to theinvention.

FIG. 3C illustrates an embodiment of an implant according to theinvention.

FIGS. 4 and 5 illustrate an embodiment of a self-fixating tip accordingto the invention.

FIG. 6 illustrates exemplary placement of elements of an implantaccording to the invention.

FIG. 7 illustrates an embodiment of a portion of an implant according tothe invention.

FIG. 8 illustrates exemplary placement of elements of an implantaccording to the invention.

FIG. 9 illustrates exemplary placement of elements of an implantaccording to the invention.

FIGS. 10 and 11 illustrate features of an embodiment of an insertiontool according to the invention.

FIG. 12A, 12B, 12C, 12D, and 12E, illustrate features of embodiments ofinsertion tools according to the invention.

FIGS. 13A and 13B, illustrate features of an embodiment of an insertiontool according to the invention.

FIGS. 14A, 14B, and 14C illustrate features of an embodiment of aninsertion tool according to the invention.

FIG. 15 illustrates an embodiment of a portion of an implant accordingto the invention.

FIG. 16A illustrates an embodiment of a kit according to the invention,the kit including an implant and an insertion tool.

FIGS. 16B and 16C illustrate embodiments of implants according to theinvention.

FIG. 17 illustrates exemplary placement of elements of an implantaccording to the invention.

FIG. 18 illustrates an embodiment of a portion of an implant accordingto the invention.

FIG. 19 illustrates exemplary placement of elements of an implantaccording to the invention.

FIGS. 20A, 20B, 20C, and 20D illustrate an embodiment of a self-fixatingtip according to the invention.

FIGS. 21A and 21B illustrate an embodiment of a portion of an implantaccording to the invention.

FIGS. 22A and 22B illustrate an embodiment of a portion of an implantaccording to the invention.

FIGS. 23A and 23B illustrate an embodiment of a portion of an implantaccording to the invention.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

The present invention is directed to surgical instruments, assemblies,and implantable articles for treating pelvic floor disorders such asfecal or urinary incontinence, including stress urinary incontinence(SUI), prolapse, etc. According to various embodiments, a surgicalimplant can be used to treat a pelvic condition, including the specificexamples of implanting a support member (“implant”) to treat a conditionsuch as vaginal vault prolapse or incontinence (male or female).Described are various features of surgical implants, surgical tools,surgical systems, surgical kits, and surgical methods, useful forinstalling implants. An implant can be implanted in a male or a femaleto treat disorders such as urge incontinence, mixed incontinence,overflow incontinence, functional incontinence, fecal incontinence, orfor female conditions including prolapse (e.g. vaginal or uterine),enteroceles (e.g. of the uterus), rectoceles, cystocele, and anatomichypermobility.

An implant can include a tissue support portion (or “support portion”)that can be used to support pelvic tissue such as the urethra (whichincludes the bladder neck), vaginal tissue, etc. During use, the tissuesupport portion is typically placed in contact with and attached totissue to be supported, such as with a suture. An implant canadditionally include one or more extension portions (otherwise known as“end” portions or “arms”) attached to the tissue support portion.Examples of pelvic implants are described in the following exemplarydocuments: U.S. patent application Ser. No. 10/834,943, filed Apr. 30,2004; U.S. patent application Ser. No. 10/306,179, filed Nov. 27, 2002;U.S. patent application Ser. No. 11/347,063, filed Feb. 3, 2006; U.S.patent application Ser. No. 11/347,596, filed Feb. 3, 2006; U.S. patentapplication Ser. No. 11/347,553, filed Feb. 3, 2006; U.S. patentapplication Ser. No. 11/347,047, filed Feb. 3, 2006; U.S. patentapplication Ser. No. 11/346,750, filed Feb. 3, 2006; U.S. patentapplication Ser. No. 11/398,368, filed Apr. 5, 2005; U.S. patentapplication Ser. No. 11/243,802, filed Oct. 5, 2005; U.S. patentapplication Ser. No. 10/840,646, filed May 7, 2004; and Internationalpatent application number PCT/US2006/028828, having an InternationalFiling Date of Jul. 25, 2006; the entireties of each of thesedisclosures being incorporated herein by reference.

An implant may include portions or sections that are synthetic or ofbiological material (e.g., porcine, cadaveric, etc.). Extension portionsmay be, e.g., a synthetic mesh such as a polypropylene mesh. The tissuesupport portion may be synthetic (e.g., a polypropylene mesh) orbiologic. Examples of implant products that may be similar to thoseuseful according to the present description, include those soldcommercially by American Medical Systems, Inc., of Minnetonka Minn.,under the trade names Apogee® and Perigee® for use in treating pelvicprolapse (including vaginal vault prolapse, cystocele, enterocele,etc.), and Sparc®, Bioarc®, and Monarc® for treating urinaryincontinence.

Exemplary implants can include a tissue support portion for placing incontact with tissue to be supported and one or more “extension”portions, the tissue support portion being useful to support a specifictype of pelvic tissue such as the urethra, bladder, or vaginal tissue(anterior, posterior, apical, etc.). The tissue support portion can besized and shaped to contact the desired tissue when installed, e.g., asa “sling” or “hammock,” to contact and support pelvic tissue. A tissuesupport portion that is located between two or more extension orextension portions is sometimes referred to herein as a “central supportportion” or a “support portion.”

Extension portions are elongate pieces of material that extend from thetissue support portion and either are or can be connected to the tissuesupport portion, and are useful to attach to anatomical features in thepelvic region (e.g., using a self-fixating tip) to thereby providesupport for the tissue support portion and the supported tissue. One ormultiple (e.g., one, two, or four) extension portions can extend fromthe tissue support portion as elongate “ends,” “arms,” or “extensions,”useful to attach to tissue in the pelvic region, such as by extendingthrough a tissue path to an internal anchoring point as describedherein.

An example of a particular type of pelvic implant is the type thatincludes supportive portions including or consisting of a centralsupport portion and either two, four, or six elongate extension portionsextending from the central support portion. An implant that has exactlytwo extension portions can be of the type useful for treating, e.g.,urinary incontinence, anterior vaginal prolapse, posterior vaginalprolapse; an implant having four or six extension portions can be usefulfor treating combinations of these conditions. The term “supportiveportions” refers to portions of an implant that function to supporttissue after the implant has been implanted, and specifically includesextension portions and tissue support portions, and does not includeoptional or appurtenant features of an implant such as a sheath orself-fixating tip or other type of connector for attaching the implantto an insertion tool.

Types of exemplary implants that can be generally useful as discussedherein can include those previously and currently used in treatingpelvic conditions, including those implants referred to as urethral“slings,” “strips,” “mesh strips,” “hammocks,” among other terms forpelvic implants. Examples of implants for treating incontinence, e.g.,urethral slings, can comprise a central support portion and twoextension portions, and may take the form of an integral mesh strip. Anexemplary urethral sling can be an integral mesh strip with supportiveportions consisting of or consisting essentially of a central supportportion and two extension portions. Examples of urethral slings fortreating male urinary incontinence can have a widened central supportportion, as discussed, for example, in Assignee's copending U.S. patentapplication Ser. Nos. 11/347,047 and 11/347,553. Other exemplaryurethral sling implants are described in Assignee's copending U.S.patent application Ser. Nos. 10/306,179; 11/347,596; 11/346,750; amongothers.

Examples of implants for treating vaginal prolapse can comprise acentral support portion and from two to four to six extension portions,and may take the form of an integral piece of mesh or multiple pieces ofmesh attached in a modular fashion. See, e.g., Assignee's copending U.S.patent application Ser. Nos. 11/398,369; 10/834,943; 11/243,802;10/840,646; PCT/2006/028828; among others.

Dimensions of an implant can be as desired and useful for any particularinstallation procedure, treatment, patient anatomy, and to support aspecific tissue or type of tissue. Exemplary dimensions can besufficient to allow the tissue support portion to contact tissue to besupported, and to allow extension portions to extend from the tissuesupport portion to a desired anatomical location to allow the extensionportion be secured to anatomy of the pelvic region, to support thetissue support portion.

Dimensions of extension portions according to the invention can allowthe extension portion to reach between a tissue support portion placedto support pelvic tissue (at an end of the extension portion connectedto the tissue support portion) and a location at which the distal end ofthe extension portion attaches to pelvic tissue. A distal end of anextension portion, according to embodiments of the invention, caninclude a self-fixating tip that can be attached directly to pelvictissue such as pelvic muscle, ligament, or tendon. The length of theextension portion, therefore, can be in a range that allows placement ofa tissue support portion as desired to support pelvic tissue, while theself-fixating tip is installed in pelvic tissue.

As described elsewhere herein, a length of an extension portion canoptionally be fixed (i.e., the extension portion does not include anyform of length-adjusting mechanism), as can a length of an implantspanning from opposite self-fixating tips and including extensionportions and a length or segment of tissue support portion. Alternateembodiments of implants of the invention may include adjustment ortensioning mechanisms that allow a physician to alter the length of anextension portion before, during, or after implantation. On the otherhand, adjustment and tensioning mechanisms can also be excluded fromembodiments of implants of the invention by selecting the length ofextension portions and tissue support portions, and by adjusting fortensioning or positioning of extension portions and tissue supportportions based on placement of the self-fixating tip within the pelvictissue, selected placement including selection of the point of insertionof a self-fixating tip and depth of insertion of the self-fixating tip.

As an example, implants for treating incontinence, prolapse, or amixture of incontinence and prolapse, can include a portion useful tosupport the urethra or bladder neck to address urinary incontinence. Forexample a urethral sling is used exclusively to support the urethra orbladder neck, and may be in the form of a mesh strip that includes asupport portion implanted below the urethra or bladder neck. Implantsfor prolapse, especially anterior prolapse, can also include andanterior portion useful for supporting the urethra or bladder neck inthe same fashion. A preferred distance between distal ends of extensionportions designed to support the urethra or bladder neck can be of atotal length between distal ends (e.g., self-fixating tips) to allow thecombined length of extension portions and tissue support portion toextend from a right obturator foramen to a left obturator foramen, e.g.,from one obturator internus muscle to the other obturator internusmuscle. This length is shown at FIG. 3C as length L2 betweenself-fixating tips 182 (the length including the length of both of theself-fixating tips) of anterior extension portions of prolapse implant180, and at FIG. 3B as length L2 between self-fixating tips 172 ofurethral sling 170. Useful lengths of extension portions are as desired,and are exemplified elsewhere in the present description.

According to embodiments of implants and methods, a fixed-length implantor implant portion (e.g., as exemplified in all of FIGS. 3A, 3B, and3C), including no length-adjusting mechanism, can be placed with desiredpositioning and effect (e.g., supportive force, approximation, or both)on pelvic tissue, by selective placement of self-fixating tips withinpelvic tissue. The implant and self-fixating tips can exhibit desirable“adjustability” or “positionability” features, without the need for alength-adjusting mechanism, as follows. Each self-fixating tip of animplant or anterior implant portion can be placed within a pelvic tissuesuch as tissue of the obturator foramen, with properties ofself-fixating tips (e.g., dimensions, pullback force, number of lateralextensions) and implant (dimensions such as length between self-fixatingtips) being sufficient to allow this placement at tissue on one or bothsides of the pelvic region (e.g., at opposing obturator foramen), whilethe tissue support portion of the implant or implant portion supportsthe urethra, bladder neck, vaginal tissue, etc. Desired position of theimplant, the amount of approximation of the supported tissue (e.g.,urethra), or the amount of supportive force placed on the supportedtissue, can be achieved by selecting the placement of the self-fixatingtips. Placement can include the position at which the self-fixating tipis inserted into tissue (the point of insertion) such as the placementof a tip within tissue of an obturator foramen relative to the entirearea of the tissue of the obturator foramen (or another muscle, tendon,or ligament, etc.), and (if the pelvic tissue includes sufficient depth)can also include the depth to which the self-fixating tip is placed(penetrated) into pelvic tissue such as a muscle in the pelvic region,e.g., tissue of the obturator foramen or the obturator internus muscle.Each of the point of insertion, and depth of insertion, can beseparately selected to result in a desired position of the implant,tension on the implant, approximation of pelvic tissue, or supportiveforce applied to pelvic tissue to be supported by the implant.

With regard to placement of a self-fixating tip at an obturator foramen,tissue of the obturator foramen, meaning the obturator internus muscle,the obturator membrane, and the obturator externus muscle, may have acombined thickness in the range from about 1 to about 2 centimeters. Anobturator internus muscle may have a thickness in the range from 0.5 to1 centimeter. These are rough approximations and thicknesses willdepend, e.g., on anatomy of a particular patient. A self-fixating tip asdescribed herein may be installed at any location (point of insertion)within tissue spanning an area of the obturator foramen, and at anydepth of penetration into tissue of the obturator foramen, e.g.,obturator internus muscle. The self-fixating tip may be passed into theobturator internus muscle, optionally into or through the obturatormembrane, and optionally into the obturator externus muscle. It may bepreferred to avoid penetration of the obturator membrane.

A self-fixating tip may enter tissue at an angle that is perpendicularto the tissue, or at an angle that may be as much as 30 degrees, 45degrees, or possibly more, from perpendicular. If the self-fixating tipenters at an angle non-perpendicular to the tissue, the self-fixatingtip may effectively extend through an amount of tissue that is greaterthan the thickness of the tissue measured at a perpendicular length ordepth.

The ability to select point of insertion and depth of penetration of aself-fixating tip into a tissue is a feature of exemplary self-fixatingtips and their methods of use, according to the invention, that allows asurgeon to select a location of an implant, to select an amount oftension placed on an installed implant, to place a desired amount ofsupportive force on a supported pelvic tissue, or combinations of these.With this feature, embodiments of the invention may avoid the need for aseparate length-adjustment or tensioning mechanism, and embodiments ofimplants according to the invention can optionally exclude any sort oflength-adjustment feature or tension-adjustment feature; these featuresinclude the use of separate implant pieces that can be secured togetheras desired to select a length of an extension portion or length of animplant, the use of sutures to adjust a length of an extension portionor implant, adjustable mechanical fasteners, or other cinching ormechanical mechanisms that allow a surgeon to increase or decrease alength of an extension portion or implant either before, during, orafter implantation.

An example of this advantageous feature of the invention can bedescribed with respect to placement of a urethral sling withself-fixating tips placed at opposing obturator foramen. While thisexample is in terms of self-fixating tips of a urethral sling placed attissue of the obturator foramen, alternately, instead of a urethralsling, the same method and advantage can be applied to implantation ofother supportive implants such as an anterior portion of an implant totreat prolapse, to support the urethra or vaginal tissue, or both, totreat a condition of vaginal prolapse, urethral incontinence, orcombined vaginal prolapse and urinary incontinence. As other alternatemethods an extension portion may be placed at a pelvic tissue other thanthe obturator foramen, such as at a different muscle, or at a ligamentor tendon e.g., the arcus tendineus, sacrospinous ligament, uterosacralligament, levator ani, etc. A tendon or ligament may have a depth lessthan a depth of a muscle tissue, in which case a surgeon may stillselect a point of entry, if not a depth of penetration, to place animplant (e.g., of fixed length) in a manner that can control location,tension, or supportive force, as stated.

According to this exemplary advantageous technique, a physician (e.g.,surgeon) is able to place an implant between locations at oppositetissues of the obturator foramen to position the implant to support theurethra, without the need for an adjustment feature designed into theimplant. The surgeon inserts a first self-fixating tip in tissue of oneobturator foramen, preferably in the obturator internus muscle, at adesired position (i.e., point of entry relative to the total area of theobturator foramen) and a desired depth. The obturator internus musclehas enough depth to allow the self-fixating tip to be placed at avariety of depths within the thickness of the muscle. For example, theself-fixating tip may be inserted to any depth at which the lateralextensions are able to resist movement back in a direction opposite ofthe direction of insertion, such as by penetrating a selected depth intothe obturator internus muscle. The self-fixating tip may be inserted ina direction perpendicular to the muscle or at an angle (resulting in agreater effective depth within which a self-fixating tip may bepenetrated). The second self-fixating tip located on the oppositeextension portion of the implant can be inserted into tissue of theopposite obturator foramen, preferably the obturator internus muscle,and the position or tension or both of the implant below the urethra, orthe amount of support, approximation, or both, of the urethra providedby the sling, etc., can be selected, controlled, or adjusted by thedepth and placement of the self-fixating tips within the tissue of theopposite obturator foramen.

Because these exemplary embodiments of implants and their extensionportions do not require either a length-adjusting or a tension-adjustingmechanism, these embodiments of implants of the invention can include afixed length of implant material separating two opposing self-fixatingtips. A “fixed” length of material can mean that the implant does notinclude a length-adjusting feature such as discussed elsewhere herein,but still may exhibit an amount of elasticity or other normal mechanicalproperties of an implant material. A fixed length of implant materialcan be of a single piece of material (integral), or may be of multiplepieces secured together in a manner that does not allow furtheradjustment of the length. For example, multiple pieces of identical meshmaterial may be assembled into a single implant, before implanting theassembled implant, by sewing or otherwise attaching pieces together.Pieces of different types of mesh materials may be sewn or otherwisesecured together, or pieces of synthetic material may be sewn orotherwise secured to a biologic material, in a manner that does notallow for adjustment of dimensions of the assembled implant.

The length of a urethral sling or an anterior portion of an implant,between distal ends of extension portions, can be sufficient to placeopposing self-fixating tips at positions and depths of tissue of theobturator foramen, preferably without penetrating the obturatormembrane, with the implant reaching between the opposing obturatorforamen while supporting the urethra. Exemplary lengths of an implant orimplant portion for extension below the urethra, between opposingobturator foramen, from distal end to distal end of the extensions whilelaying flat, can be in the range from about 6 to 15 centimeters, e.g.,from 7 to 10 centimeters or from 8 to 9 centimeters or about 8.5centimeters. (Lengths L1 and L2 of FIGS. 3B and 3C can be within theseranges.) The lengths are for male and female urethral slings, and arefor anterior portions of implants for treating female prolapse orcombined female prolapse and incontinence, which include an anteriorportion that has a length between ends of anterior extensions portionswithin these same ranges.

A width of the extension portion can be as desired, such as within therange from about 1 to 1.5 centimeters.

An extension portion of an implant of the invention can include aself-fixating tip at an end of the extension portion that is distal froma tissue support portion. The self-fixating tip in general can be astructure connected to a distal end of an extension portion and that canbe implanted into tissue in a manner that will maintain the position ofthe self-fixating tip and the attached implant. Exemplary self-fixatingtips can also be designed to engage an end of an insertion tool (e.g.,elongate needle, elongate tube, etc.) so the insertion tool can be usedto push the self-fixating tip through tissue for implantation. Theself-fixating tip may engage the insertion tool at an internal channelof the self-fixating tip, at an external location such as at the base,or at a lateral extension, as desired.

A self-fixating tip can be made out of any useful material, generallyincluding materials that can be molded or formed to a desired structureand connected to or attached to an end of an extension portion of animplant. Useful materials can include plastics such as polyethylene,polypropylene, and other thermoplastic or thermoformable materials, aswell as metals, ceramics, and other types of biocompatible andoptionally bioabsorbable or bioresorbable materials. Exemplarybioabsorbable materials include, e.g., polyglycolic acid (PGA),polylactide (PLA), copolymers of PGA and PLA,

A self-fixating tip also, preferably, includes one or more lateralextensions that can increase the force required to remove theself-fixating tip from tissue after insertion into the tissue, i.e. the“pullout force.” At the same time, the lateral extensions can bedesigned to exhibit a reduced or relatively low “insertion force,” whichis the amount of force used to insert the self-fixating tip into tissue.The self-fixating tip is designed to be essentially permanently placedupon insertion into tissue, with the single exception that if absolutelynecessary to provide desired placement of the self-fixating tip or anattached implant, the self-fixating tip may be removed by a surgeonduring an implantation procedure. The self-fixating tip, and allcomponents of the self-fixating tip, can be of combined form anddimensions to result in these functional features.

Factors that can be balanced in designing a self-fixating tip asdescribed include insertion force and pullout force, the insertion forcebeing preferably reduced or minimized while a pullout force allowsremoval of the self-fixating tip only when desired by a surgeon duringan implantation procedure. Concurrently, the self-fixating tip designcan attempt to minimize the amount of potential trauma caused to tissueby inserting or, when necessary, removing, a self-fixating tip. Adesired combination of these factors can be achieved by selecting size,shape, and other structural features of the self-fixating tip and theelements of the self-fixating tip such as the base and lateralextensions.

Another factor that can balance the above performance properties of aself-fixating tip can be the number of lateral extensions. Aself-fixating tip can have from one to a large number of lateralextensions, but it has been found that a self-fixating tip can functionwell with a small number of fixed lateral extensions such as two or fourlateral extensions. To provide desired dimensions of a self-fixatingtip, such as reduced overall length, embodiments of self-fixating tipsinclude lateral extensions located at the same position along thelongitudinal dimension (length) of the base between the proximal baseend and the distal base end. A self-fixating tip that includes exactlytwo lateral extensions, for example, can be located opposite of eachother along a length of a base, to provide desired insertion and pulloutforces, especially by implanting the two lateral extensions to beoriented in fibrous tissue with the direction of the lateral extensionsbeing not parallel to the tissue fibers, for example being perpendicularto the fibers (or “across the grain”). Also, a relatively low number oflateral extensions, such as two, can desirably reduce the amount oftrauma when, as may become necessary at the discretion of a surgeonduring implantation, a self-fixating tip must be withdrawn from tissueafter placement.

Another feature of a self-fixating tip according to the presentinvention can be sizes of the base, lateral extensions, or both, toallow the self-fixating tip to be inserted into tissue at a selecteddepth. As an example, a lateral extension that will be placed intomuscle tissue can have a length dimension (measured along a longitudinalaxis of the base) that allows the self-fixating tip to be inserted intothe tissue at any selected depth along the thickness of the tissue. Thiscan mean that the length dimension of the lateral extension is shorterthan the total depth of the muscle tissue.

A base of a self-fixating tip can be of any desired size, shape, anddimension (e.g., length, diameter, width). A diameter of a cylindricalbase can be any useful size, for example from about 2 to about 5millimeters. The diameter may be uniform along the length of the base,between a base proximal end and a base distal end, or a diameter maychange. For example, a diameter of a base may be greater at a proximalend, and taper to a reduced diameter at a distal end, to optionallyreduce insertion force or increase pullout force. The diameter ordiameter profile of a base may preferably be relatively small, e.g.,minimized, to reduce trauma to tissue when implanted or removed. Thediameter can also be sufficient to allow placement of a desired numberof lateral extensions around the perimeter of the base.

Exemplary self-fixating tips discussed herein include a cylindrical baseor tapered cylindrical base, with a hollow or solid interior. Othershapes for a base may also be useful, such as blocks having square orrectangular forms when viewed in cross section along a longitudinal axisextending from a proximal base end to a distal base end. For those typesof self-fixating tips, dimensions of a square or rectangular crosssection can be of a range similar to the diameter of a cylindrical base,such as from about 2 to about 5 millimeters in either dimension whenviewed in cross section.

As an example of a specific range of a length of a self-fixating tip,lengths (measured from the proximal base end to the distal base endalong a longitudinal axis of the self-fixating tip) in the range from0.4 to 1.0 centimeter, e.g., from 0.4 to 0.8 centimeters, or from 0.4 to0.7 centimeters, have been found to be useful. These ranges arespecifically useful for self-fixating tips that can be inserted intomuscle of the obturator internus, because the relatively short lengthcan allow the self-fixating tip to be inserted into the muscle tissue adesired depth, i.e., over a range of depths, optionally withoutpenetrating the obturator membrane; the self-fixating tip can be of alength dimension that is less than the thickness of the muscle, so theself-fixating tip can be inserted a desired distance into the muscle.

According to exemplary embodiments, a self-fixating tip can havestructure that includes a base having a proximal base end and a distalbase end. The proximal base end can be connected (directly orindirectly, such as by a connective suture) to a distal end of anextension portion of an implant. The base extends from the proximal baseend to the distal base end and can optionally include an internalchannel extending from the proximal base end at least partially along alength of the base toward the distal base end. The optional internalchannel can be designed to interact with (i.e., engage) a distal end ofan insertion tool to allow the insertion tool to be used to place theself-fixating tip at a location within pelvic tissue of the patient.

Alternate embodiments of self-fixating tips do not require and canexclude an internal channel for engaging an insertion tool. Thesealternate embodiments may be solid, with no internal channel, and mayengage an insertion tool, if desired, by any alternate form ofengagement, such as, for example, by use of an insertion tool thatcontacts the self-fixating tip at an external location such as bygrasping the base (on a side or at the face of the proximal base end) orby contacting a lateral extension.

Embodiments of self-fixating tips also include one or more lateralextension extending laterally (e.g., radially) from the base, such asfrom a location between the proximal end and the distal end, from alocation at the distal base end, or from a location at the proximal baseend.

Exemplary lateral extensions can be rigid or “fixed” relative to thebase so the lateral extension does not substantially move or deflectduring or after implantation. For example, a fixed lateral extension canbe a lateral extension that is not substantially moveable relative tothe base in a manner that certain types of known soft tissue anchorextensions are moveable, for instance between a non-deployed ornon-extended position that places an extension against the base to allowinsertion of the anchor into tissue with a reduced size or shapeprofile, and a deployed or extended position that places the extensionaway from the base to engage tissue and prevent movement of theself-fixating tip in a direction opposite of the direction of insertion.Alternate embodiments of lateral extensions can be moveable ordeflectable, if desired, such as to allow a reduced insertion force byuse of lateral extensions that deflect backward when a self-fixating tipis being pushed through tissue.

A lateral extension can have a three-dimensional form that results in abalance of the performance factors discussed herein, including insertionforce, pullout force, and reduced trauma caused to tissue duringinsertion or in the event of a need to remove the self-fixating tipduring an implantation procedure. A lateral extension can include athree-dimensional form referred to as an extension body defined as thelateral extension material between a leading edge, a trailing edge, anda boundary at which the lateral extension connects to a base; away fromthe boundary of the lateral extension and the base, the far lateral edgeof a lateral extension may include a point of connection of the trailingedge and the leading edge, or another segment or connection may connectthe leading edge with the trailing edge away from their respectiveconnections to the base. The “leading edge” means the boundary of thelateral extension on the side of the lateral extension toward the basedistal end, which is also the edge that leads the lateral extension bodyand contacts tissue first as the self-fixating tip is inserted intotissue by pushing. The “trailing edge” means the boundary of the lateralextension on the side of the lateral extension toward the base proximalend, which is also the edge that trails behind the lateral extensionbody and passes through or contacts tissue last when the self-fixatingtip is inserted into tissue by pushing.

The lateral extension body can exhibit a thickness or thickness profileas desired, such as a uniform thickness or a varied thickness across theextended area of the body. For example, embodiments of implants mayinclude a leading edge of a low profile, e.g., reduced thickness or evensharpened, to allow for reduced insertion force. According to theseembodiments, the thickness of the lateral extension body can reducegradually or taper from a central portion of the body (away from edges)in the direction of a leading edge. A leading edge, being of a reducedthickness to reduce insertion force, may optionally in addition exhibita form that extends in a direction back toward the trailing edge, i.e.,a “swept-back” leading edge, to further reduce insertion force. Theshape of the leading edge may be linear or arcuate, and if arcuate maybe convex or concave. Optionally the leading edge may take an arcuateconvex path that sweeps back to meet the trailing edge at a singlelateral extension point away from the base. E.g., see the exemplaryself-fixating tip illustrated at FIG. 1.

The direction and shape of the trailing edge of a lateral extension, asthe edge extends away from the base (e.g., when viewed as in FIG. 1),may be linear or arcuate, and if arcuate may be convex or concaverelative to the lateral extension body. A trailing edge can be asdesired, such as arcuate, straight, convex, flat, linear, rounded,tapered, sharp, blunt, etc. Optionally a trailing edge can exhibit athickness (a thickness dimension is illustrated, e.g., at FIG. 2) toproduce increased pullout force, yet that does not result in unduetrauma in the event that a self-fixating tip must be removed from tissueafter insertion.

Viewing the trailing edge along the longitudinal axis of the base andlooking at the proximal base end (as in FIG. 2), a trailing edge canexhibit an area that includes a width (w, the distance the trailing edgeextends laterally away from the base) and a thickness (t, the distanceperpendicular to the width and the longitudinal axis of theself-fixating tip). An exemplary width (w, in FIG. 2) of the trailingedge can be, e.g., in the range from 0.5 to 3 millimeters.

An exemplary thickness at a trailing edge may be the same as a thicknessat an interior or central portion of the lateral extension (away fromthe leading and trailing edges), or a thickness at a trailing edge maybe a maximum thickness of the entire lateral extension, meaning forexample that the thickness increases from a narrow thickness at theleading edge and widens gradually to a maximum thickness at the trailingedge. A thickness of a trailing edge can be, e.g., in the range from 0.2to 2 millimeters, e.g., from 0.5 to 1.5 millimeters.

Based on the above-recited exemplary thickness and width dimensions, asurface area of a trailing edge may be, e.g., from the range from 0.25to 5 square millimeters, e.g., from 0.5 to 4, or from 1 to 3 squaremillimeters. The surface area of the trailing edge may be concave,convex, rounded, tapered (symmetrically or toward one or the othersurfaces of the lateral extension), etc. A flat surface may bepreferred, to provide increased or maximum pullout force for preventingremoval of the self-fixating tip after implantation.

A lateral extension can also include a third dimension that can bereferred to as a “length” dimension (shown as “L” at FIG. 1). A lengthcan be measured at a location where the lateral extension meets orextends from the base. This length dimension can become smaller as thelateral extension extends from the base. An exemplary length of alateral extension at the location of the lateral extension meeting thebase can be, e.g., from 0.5 to 5 millimeters, such as from 1 to 4millimeters or from 1.5 to 3.5 millimeters.

In the specific example of a self-fixating tip for insertion to tissueof the obturator foramen, an exemplary length of a lateral extension canbe a length that is less than the total thickness of obturator foramentissue (i.e., the combined thickness of obturator internus muscle,obturator membrane, and obturator externus muscle); a length of alateral extension intended to be inserted into the obturator internusmuscle can be a length that is a portion of the thickness of theobturator internus, e.g., less than 1 centimeter, such as less than 0.5centimeter.

As noted, a self-fixating tip can include multiple lateral extensions atmultiple locations, either at different positions along a length of abase, at different locations around a perimeter of a base, or both. Withself-fixating tips of reduced dimensions (to achieve functionality asdescribed), a self-fixating tip may preferably include all lateralextensions originating from the same position along a length of a base,e.g., a single set of lateral extensions can be arranged around aperimeter of a base, each extending in a different direction but fromthe same portion of length between the proximal base end and the distalbase end. See, e.g., FIGS. 1, 3A, 3B, 3C, 4, and 5.

A self-fixating tip can be connected to an extension portion of animplant in any fashion, directly by any attachment mechanism, orindirectly such as through an attachment structure such as a suture. Aconnection can be based on a mechanical structure, by adhesive, by aconnecting suture, or by an integral connection such as by injectionmolding or “insert” molding (also, “overmolding”) as described U.S.Publication No. 2006-0260618-A1, incorporated herein by reference.According to that description a thermoplastic or thermosetting polymermaterial can be insert molded or injection molded at an end of a meshextension portion of an implant, e.g., directly to the mesh. By thismethod, a molded polymer can form a self-fixating tip at an end of anextension portion. The self-fixating tip can be as described herein, forexample, including lateral extensions and an internal channel.

A single example of a self-fixating tip, for purposes of non-limitingillustration and explanation, is at FIG. 1. FIG. 1 shows self-fixatingtip 10, including base 12 (for attachment to an implant extension end),proximal base end 14, distal base end 16, internal channel 18, and twolateral extensions 20 located on outer surfaces and on opposite sides ofbase 12. Tip 10 can be prepared from a biocompatible material,preferably a biocompatible material such as a biocompatible polymer,which may optionally be bioresorbable or bioabsorbable. Exemplaryself-fixating tip 10 as illustrated includes internal channel 18(optional according to the invention) which is an opening within base 12extending from proximal end 14 toward distal end 16 along at least aportion of the total longitudinal length of base 12. Internal channel 18is capable of receiving a distal end of an elongate needle of aninsertion tool to allow tip 10 to be pushed into position within pelvictissue during an implant installation procedure. Lateral extensions 20include leading edge 24 and trailing edge 26. Leading edge 24 originatesat base 12 and extends away from base 12 along an arcuate pathwaysweeping back toward proximal base end 14, meeting trailing edge 26 atpoint 28. Leading edge 24 can preferably include a reduced thickness ora sharp or sharpened edge. Trailing edge 26 is shown to be relativelystraight but could alternately be arcuate, concave, or convex. Trailingedge 26 has a flat surface area. Trailing edge 26 is also shown to sweepslightly back in a proximal direction, although it could alternatelyextend straight away from (i.e. perpendicular to) base 12 or extend awayfrom base 12 in a direction that includes a forward component, i.e., adirectional component in the direction of distal base end 16.

Referring now to FIG. 2, self-fixating tip 10 is viewed in a directionlooking at proximal base end (surface) 14 along a longitudinal axis ofbase 12. In this view, surface areas of lateral extensions 20 are shownas flat surfaces of approximately the area of thickness (t) by width(w). Also visible in FIG. 2 is interior surface 22 of internal channel18 of base 12. Surface 22 functions to orient self-fixating tip 10 in adesired rotational orientation relative to a distal end of a needle ofan insertion tool; the distal end of the needle can be provided with aflat surface that is complementary to surface 22. As will beappreciated, surface 22 does not need to be a flat surface but could beany other type of surface or protrusion such as a rounded surface,angled surface, key structure, edge, or other feature that can orient aself-fixating tip rotationally relative to a distal end of an insertionneedle.

An insertion tool can be used to install the implant. Various types ofinsertion tools are known, and these types of tools and modificationsthereof can be used according to this description to install an implant.Examples of useful tools include those types of tools that generallyincludes a thin elongate needle that attaches to a handle; a handleattached to one end (a proximal end) of the needle; and a distal end ofthe needle adapted to engage a self-fixating tip that allows the needleto push the self-fixating through a tissue passage and insert theself-fixating tip within tissue of the pelvic region. This class of toolcan be used with a self-fixating tip that includes an internal channeldesigned to be engaged by a distal end of an insertion tool. Othergeneral types of insertion tools will also be useful, but may engage aself-fixating tip in a manner that does not involve an internal channelof a self-fixating tip. These alternate insertion tools may for examplecontact or grasp a proximal base end of a self-fixating tip in theabsence of an internal channel extending from the proximal base endtoward the distal base end, such as by grasping an external surface ofthe base. An alternate insertion tool may contact or grasp a side of thebase, a lateral extension, or any other portion of the self-fixating tipor base, in a way that allows the insertion tool to hold theself-fixating tip and insert the self-fixating tip at a desired locationwithin tissue of the pelvic region.

Exemplary insertion tools for treatment of incontinence and vaginalprolapse are described, e.g., in U.S. patent application Ser. Nos.10/834,943, 10/306,179; 11/347,553; 11/398,368; 10/840,646; PCTapplication number 2006/028828; and PCT application number 2006/0260618;among others. Tools described in those patent documents are designed forplacement of an implant in a pelvic region for the treatment ofprolapse, male or female incontinence, etc. The tools of theabove-referenced patent documents may be curved in two or threedimensions, and may include, for example, a helical portion in threedimensions for placing an extension portion of an implant through atissue path that passes from a region of the urethra, through anobturator foramen, to an external incision in the groin or inner thigharea. Other described insertion tools include a two-dimensional elongateneedle that allows a user to place an extension portion of an implantthrough an external incision in the perirectal or coccyx region of thelower back and buttock area.

Exemplary insertion tools for use according to the invention can besimilar to or can include features of tools described in theabove-referenced patent documents. For use according to methodsdescribed herein, those insertion tools may be modified to allow theinsertion tool to be used to place a self-fixating tip at tissue withinthe pelvic region through a tissue path that does not extend to anexternal incision. The insertion tool can be designed, shaped, andsized, to include an elongate inserter or needle that may be straight orthat may be curved in two or three dimensions, that can be insertedthrough a vaginal incision (for female anatomy) or through a perinealincision (for male anatomy), and to extend from that incision to apelvic tissue location for placement of a self-fixating tip.

Some previous insertion tools are designed to reach through a vaginal orperineal incision, through an internal tissue path and to then extendthrough a second external incision, e.g., at the inner groin, thigh,abdominal area, or perirectal region. As opposed to those types ofinsertion tools, exemplary insertion tools for use according toembodiments of presently described methods can be sized and shaped toplace a self-fixating tip at an internal location of the pelvic region,and do not need to be sufficiently long to extend from a vaginal orperirectal incision to an external incision. The length can be onlysufficient to reach from a vaginal or perirectal incision to anobturator foramen, for example. Alternately, the length may be onlysufficient to reach from a vaginal or perirectal incision to a differentmuscle or tissue, such as a levator ani, coccygeous muscle,iliococcygeous muscle, arcus tendineus, sacrospinous ligament, etc., toplace a self-fixating tip at one of those tissues.

According to preferred methods of the invention, a self-fixating tip maybe placed into pelvic tissue that is a fibrous tissue such as muscle,ligament, or tendon, with specific examples including the arcustendineus, the obturator internus muscle, the levator ani, and thesacrospinous ligament. Preferably, an elongate portion (e.g., elongateinserter, elongate needle, etc.) of an insertion tool can include anengagement surface for contacting a self-fixating tip, the engagementsurface being in the form of any one of an internal channel or anexternal surface, channel, extension, or other structure. Acomplementary surface of a self-fixating tip (internally or at anexterior surface such but not necessarily the base), can be designed toplace tip at an orientation so that lateral extensions of aself-fixating tip (i.e., the extended or “width” direction of lateralextensions) are implanted within the fibrous tissue at an orientationthat places the lateral extensions in a direction that is non-parallelto the fibers of the fibrous tissue, e.g., that is at an angle of atleast 45 degrees to the direction of the fibers, such as at an angle inthe range from 50 to 130 degrees, or from 60 to 120 degrees, or from 70to 110 degrees, preferably perpendicular to the fibers. In certainembodiments of the methods and devices of the invention, placing lateralextensions in such a non-parallel orientation can increase pulloutforce. In these embodiments, exemplary self-fixating tips can includeonly two lateral extensions located on opposite sides of a base.

As a specific example of the above concept of designing an insertiontool and self-fixating tip to place lateral extensions at a non-parallelorientation to fibrous tissue, this can be done for a urethral slingimplant that will include a self-fixating tip placed at the obturatorforamen, e.g., within the obturator internus muscle. Using a femaleanatomy as an example, an insertion tool and self-fixating tip can bedesigned to orient two lateral extensions of a self-fixating tip at anangle perpendicular to fibers of the obturator internus muscle when theneedle and tip are inserted through a transvaginal incision and a tissuepath leading to the obturator internus muscle. Based on that tissuepath, and the direction of fibers of the obturator internus muscle, ithas been found that an insertion tool that includes a curve (in twodimensions) that allows the distal end to be located at the obturatorinternus muscle when the needle is inserted through a vaginal incision,and that orients lateral extensions relatively perpendicular to (e.g.,at an angle in the range from 75 to 105 degrees, such as from 80 to 100degrees) a plane defined by the curve, will also cause the lateralextensions to enter the obturator internus muscle at an orientation thatis substantially perpendicular to the fibers of the muscle.

Orientation of a self-fixating tip and lateral extensions relative to aneedle (and tissue fibers) can be controlled using an engagement betweenthe self-fixating tip and the needle that maintains the radialorientation of the self-fixating tip relative to the longitudinal axisof the distal end of the needle. The orientation may be maintained byany desired method, such as by one or more engaging surfaces of aninternal channel of a self-fixating tip that align with one or moresurfaces of a distal end of a needle. Alternately, another surface of aself-fixating tip such as a surface of the base on the proximal baseend, on the outer surface of the base, or a lateral extension, mayprovide the desired orientation. The surfaces can be complementary, andmay include flat, curved, circular, semi-circular, rounded, “keyed,” orotherwise opposing surfaces that allow a surface of self-fixating tip toprovide desired engagement with the insertion tool. According to certainembodiments, an internal channel of a self-fixating tip can fit over alength of a distal end of a needle of an insertion tool with a single oralternate fixed radial orientations relative to an axis of an insertiontool.

Thus, an example of a combination of insertion tool and self-fixatingtip according to this description can include an elongate curved needle,hollow tube, or other “elongate inserter,” curved in two dimensions, anda self-fixating tip; the distal end of the needle, tube, or inserter,and the self-fixating tip, include complementary engaging surfaces thatcan cause the self-fixating tip to be oriented at the distal end of theneedle, tube, or inserter so that lateral extensions are oriented to beperpendicular (90 degrees, or more broadly, at an angle in the rangefrom 80 to 100 degrees) to a plane defined by the two-dimensional curve.

The elongate inserter (e.g., needle or tube) may be of a length thatallows the end of the inserter to be inserted through a perinealincision or a vaginal incision and to reach an obturator foramen,levator ani, sacrospinous ligament, or arcus tendineus. The insertiontool can be useful for placing a self-fixating tip at tissue of theobturator foramen, levator ani, sacrospinous ligament, or arcustendineus, or other tissue of the pelvic region, preferably with lateralextensions being oriented non-parallel to fibers of a fibrous tissue.

Implants as described can be useful for treating male and femaleconditions of the pelvic area. Examples of specific pelvic floordisorders are fecal and urinary incontinence such as stress urinaryincontinence (SUI) in both men and women, and prolapse conditions inwomen. The implant can be designed for a specific application with asize, shape, and number of extension portions designed to support aspecific type of pelvic tissue.

According to an aspect of the invention, an implant can include one ormultiple self-fixating tips at one or multiple ends of extensionportions, and an implantation method can include placing theself-fixating tip or tips within tissue in the pelvic region to supportthe implant as the implant supports a type of pelvic tissue. The tissuecan be a fibrous tissue such as a muscle (e.g., of the obturatorforamen, obturator internus, obturator externus, levator ani,coccygeous, iliococcygeous), ligament (e.g., sacrospinous ligament),tendon (arcus tendineus), etc. Also preferably, but not as a requirementof the invention, a self-fixating tip can be oriented in a fibroustissue to cause a major dimension (referred to herein as the “width”) ofa lateral extension to be oriented in a direction that is not parallelto the direction of the fibers.

To control the placement and degree of support of the implant relativeto a tissue to be supported by the implant, the self-fixating tip can beinserted at a desired point of entry relative to the total area of thetissue, and, for tissues of sufficient thickness or depth, theself-fixating tip can be inserted to a selected depth.

A single example of a method according to the invention is a method oftreating urinary incontinence by surgical implantation of a urethralsling (e.g., a single, integral, optionally uniform, woven polymericmesh strip, with two self-fixating tips, one on each end) through avaginal (for female anatomy) or perineal (for male anatomy) incision,along a tissue path that extends from a region of the urethra to theobturator foramen. These methods can advantageously involve only asingle incision (a vaginal incision in a female or a perineal incisionin a male) and can exclude the need for any additional incision. Anelongate urethral sling is attached at tissue of the opposing obturatorforamen by self-fixating tips at opposing distal ends of the urethralsling, with the sling positioned to pass below the urethra to supportthe urethra.

An exemplary method of installing a male urethral sling can include astep of creating a perineal (e.g., medial) incision at the external maleperineum and creating opposing tissue paths from the medial incision,below the urethra, to the patient's left and right obturator foramen,and installing a urethral sling that includes extension portions withself-fixating tips for placement at tissue of the obturator foramen,e.g., the obturator internus muscle. Preferably, the self-fixating tipcan include lateral extensions (e.g., two, of the same size and shapeand form, extending in opposite directions from opposite sides of thebase). When installed, lateral extensions can be oriented in a directionthat is non-parallel to, e.g., substantially perpendicular to, fibers ofthe obturator internus muscle. The urethral sling may be placed usingone or more insertion tools as described, by installing extensionportions of the sling between the incision and the obturator foramen,with the middle (support) portion of the sling positioned below theurethra. The extension portions may be pushed through the tissue path atthe lead of an insertion tool that engages the self-fixating tip andmaintains the self-fixating tip in an orientation to enter the obturatorinternus muscle with lateral extensions non-parallel to the musclefibers. The fixed orientation is maintained, and rotation is presented,also, during insertion and passage through tissue. The tissue supportportion (central portion) of the urethral sling may be placed as desiredto support the urethra, optionally with approximation, compression, or acombination of approximation and compression. Adjustment of the implantcan be performed based on the location (point of entry) and depth ofinsertion of the self-fixating tips at tissue of the opposing obturatorforamen. The sling may be placed below the bulbospongiosus muscle orbelow the corpus spongiosum, as desired. The sling may optionallyinclude a widened central support portion that is placed to contact thecorpus spongiosum, and the support portion and sling are used toapproximate the urethra to improve continence, e.g., without the needfor compression of the urethra. See, e.g., U.S. patent application Ser.Nos. 11/347,553 and 11/347,047.

An embodiment of a kit according to the invention, including aninsertion tool and an implant, is shown at FIG. 3A. Incontinence sling100 can be installed to help maintain continence by supporting theurethra during times of increased abdominal pressure. The presentinvention also includes methods of implanting the sling 100. Sling 100can be implanted through a single incision in the vaginal wall forfemales, or perineal floor for males, and attached to (e.g., anchoredto) the obturator internus muscle on either side of the urethra. Onlyrequiring one incision in the vaginal wall (for females) or perineum(for males) eliminates additional incisions such as external incisionsused in some methods of implanting urethral slings, along with thescarring and invasiveness associated with the extra incisions. Sling 100and its methods of implantation are, therefore, a reduced or “minimally”invasive treatment option for patients suffering from urinaryincontinence. In alternate embodiments, sling 100 may be anchored atother locations besides the obturator internus muscle, such as, forexample, the obturator membrane or the obturator externus muscle. Apreferred method may be to implant sling 100 having self-fixating tipsat opposing extension portions, without penetrating the obturatormembrane. The present disclosure may focus on the obturator internusanchoring location, with the understanding that other anchoringlocations may be selected by those of skill in the art.

Referring to FIG. 3A, sling 100 may include a first anchor (i.e.,“self-fixating tip”) 120, a second anchor 122, a first anchoring arm124, a second anchoring arm 126, and a sling body (“central supportportion” or “tissue support portion” 128). As illustrated, sling body128 may be suspended between first anchoring arm 124 and secondanchoring arm 126 and may be operably attached to a first end of each124A, 126A. Second end 124B, 126B of each anchoring arm 124, 126 isattached to corresponding anchor 120, 122. The overall dimensions of thesling 100 may be 6-15 cm in length, in the range from 6 to 10, 8 to 10,10 to 15, 10 to 12, or 12 to 15 centimeters in length, and 1-2 cm, morepreferably 1-1.5 cm, in width (at the arms). The total length dimensionbetween anchors should be at least sufficient to extend from anobturator internus muscle on one side of the urethra and into anobturator internus muscle on the opposite side of the urethra.Self-fixating tips 120 and 122 include a base, optional internal channel(not shown), and four lateral extensions, and the design is to allowself-fixating tips 120 and 122 to be implanted securely within tissue ofthe obturator foramen.

FIG. 3A includes a perspective view of one implant embodiment of thepresent invention, and the invention is not limited to the particularembodiment shown. It is understood that a large number of differentsizes, shapes, and dimensions of implant (e.g., slings) will be suitableaccording to different embodiments of methods and implants describedherein. In one embodiment the sling body 128 and anchoring arms 124, 126are all substantially one piece (i.e., “integrated”) and may be ofuniform width and thickness. In such an embodiment the sling may appearas one continuous ribbon or tape. In further embodiments, sling 110 maybe an assembly of two or more pieces, e.g., different pieces of mesh orcombinations of mesh and a biologic material.

Sling body 128 may be made by being woven, knitted, sprayed, or punchedfrom a blank. In one aspect of the invention, sling body 128 may includeone or more woven, knitted, or inter-linked filaments or fibers thatform multiple fiber junctions. The fiber junctions may be formed viaweaving, knitting, braiding, or through other techniques, includingcombinations thereof. In addition, the size of the resultant openings orpores of the mesh may be sufficient to allow tissue in-growth andfixation within surrounding tissue.

The material used to make the sling body 128, arms 124 and 126, andanchors 120 and 122, may include a variety of different plastics orother materials that are strong but conducive to being used in the body,such as, but not limited to, polypropylene, cellulose, polyvinyl,silicone, polytetrafluoroethylene, polygalactin, Silastic, carbon-fiber,polyethylene, nylon, polyester (e.g. dacron) PLLA, acetols, EPTFE andPGA. Sling body 128, arms 124 and 126, and anchors 120 and 122, each mayindependently be any of resorbable, absorbable or non-absorbable;optionally, some portions may be absorbable and other portions may benon-absorbable. In further embodiments the material used to make thesling body 128 may include a non-synthetic material or a synthetic andnon-synthetic blend of materials. In addition, it may be preferable thatthe sling body 128 be relatively elastic. In other embodiments the slingmay be relatively inelastic.

Some example of commercially available materials may include MarleX™(polypropylene) available from Bard of Covington, R.I., Prolene™(polypropylene) and Mersilene (polyethylene terephthalate) Hernia Meshavailable from Ethicon, of New Jersey, Gore-TeX™ (expandedpolytetrafluoroethylene) available from W. L. Gore and associates,Phoenix, Ariz., and the polypropylene sling available in the SPARC™sling system, available from American Medical Systems, Inc. ofMinnetonka, Minn. Commercial examples of absorbable materials includeDexon™ (polyglycolic acid) available from Davis and Geck of Danbury,Conn., and Vicryl™ available from Ethicon.

First and second arms 124, 126 may likewise be made by weaving, knittingor in any of the other ways previously discussed in reference to slingbody 128. First and second arms 124, 126 may be made of the same ordifferent material as sling body 128 and may include the same ordifferent physical characteristics, such as, for example,reabsorbability. In one embodiment, first and second anchoring arms 124,126 may be a weave that results in a stronger or denser material thanthe weave used to make the sling body 128 so as to support more weightover a given surface area. In one embodiment the arms 124, 126 may notbe woven. In further embodiments, sling body 128 and the first andsecond arms 124, 126 may be made of one continuous weave structure ofthe same or different weave densities.

FIGS. 3B and 3C illustrate alternate embodiments of implants of theinvention. FIG. 3B shows urethral sling (mesh strip) 170 for supportinga male or female urethra by placement of self-fixating tips 172 attissue of the obturator foramen. Length L1 can be, e.g., about 8.5centimeters. FIG. 3C illustrates implant 180 for treating vaginalprolapse. Self-fixating tips 182 are at ends of anterior extensionportions 183, which are each connected at their opposite ends to ananterior portion of tissue support portion 184. Posterior or centralextension portions 185 are connected at one end to central portion ofsupport portion 184, and include self-fixating tips 186 at the oppositeends. Self-fixating tips 186 may be placed at tissue of the central orposterior pelvic region such as a muscle, tendon, or ligament, e.g., amuscle of the obturator foramen, levator ani, coccygeous,iliococcygeous; sacrospinous ligament; arcus tendineus. As illustrated,central portion 184 can be a biologic material, but could alternately bea mesh or other synthetic material. Extension portions 183 and 185 areillustrated to be of synthetic mesh.

As illustrated in FIG. 3A, first and second anchors 120, 122 of animplant can be substantially identical, and, as illustrated, can bedescribed with reference to anchor 120. Anchors 120, 122 may also beknown as anchor members, fixation members, self-fixating tips, orfasteners. In one embodiment, referring also to FIGS. 4 and 5, anchor120 may include a body (or “base”) 130 with a first (distal) end 132 anda second (proximal) end 134. A number of fixation wings (or “lateralextensions”) 136 may be attached to body 130 at some point or along alength between first end 132 and second end 134. In the embodimentillustrated, anchor 120 includes four fixation wings 136 spaced evenlyabout a perimeter of body 130. In alternate embodiments, anchor 120 mayinclude a greater or lesser number of fixation wings 136, positioned inany desired pattern around the body 130. Fixation wings 136 may also bereferred to as or may include barbs, extensions, fins, tines, spikes,teeth, or pins.

Fixation wings 136 may be as described elsewhere in the presentdescription, and may according to certain embodiments be in the form ofrelatively thin (a thickness in the range of millimeters or less)wing-type structures that extend generally perpendicularly from thesurface of body 130. Fixation wings 136 may extend away from body 130 toform a smoothly angled surface 138. Surface (or “edge”) 138 may extendfurther from body 130 when traveling from first end 132 toward secondend 134 in a continuous or other angular, curved, arcuate, concave,convex, or other pattern. The form of surface (or “edge”) 138 can be onethat allows for anchor 120 to be implanted through tissue in animplantation direction with reduced or minimal damage to the tissue, andreduced or minimal insertion force. Fixation wings 136 may furtherinclude tip 140. Tip 140 may be a barbed-like structure at the tail endof sloping surface 138. Tip 140 may allow for anchor 120 to resist beingwithdrawn from a desired anchoring position. Tip 140 may form a pointedtip 140 or may form a more rounded tip. In either case, tip 140 providesanchor 120 with a structure that helps to bind anchor 120 in a desiredposition in a pelvic tissue. As will be further discussed, anchors suchas anchors 120, 122 are designed for anchoring an implant to tissuerather than bone.

In alternate embodiments, fixation wing 136 may take other forms such asa barb, spike, (optionally fixed) etc., that can effectuate theimplantation of anchors 120, 122 in the desired location. In addition,body 130 of anchor 120 may include barbs and spikes in addition to thefixation wing 136. Fixation wings 136 of FIGS. 4 and 5 are fixed,meaning not substantially moveable between different positions.Alternate embodiments of self-fixating tips (e.g., “anchors”), such asanchors 120, may include fixation wings (or “lateral extensions”) 136that are moveable, e.g., that are extended or deployed to an extendedposition from body 130 after anchor 120 is in the desired position, orthat will otherwise move or deflect during or after insertion intotissue.

Embodiments of implants such as a sling 100 may further include aprotective sleeve 150, as shown in FIG. 3A. Sleeve 150 may be aprotective sheath that is placed over sling 100 or an extension portion(126) before implantation, to assist with implantation. Some slings 100may be sufficiently robust to be inserted without a protective sleeve150. However, in those situations wherein sling 100 requires additionalstructural integrity, or includes structural characteristics that maydamage the tissue of the patient during passage therethrough, sleeve 150may provide support for the implant, protection for the tissue, or both.Sleeve 150 covering mesh of sling 100 may be designed to minimize riskof contamination and to reduce abrasive “sliding” of sling 100 throughtissue of a patient. Sleeve 150 may be particularly desirable when sling100 is elastic, as sleeve 150 assists in introducing sling 100 withintissue and avoids damage to material of sling 100. After sling 100 isimplanted, sleeve 150 is removed and discarded.

Preferably, protective sleeve 150 is constructed of a material thatallows for visual examination of sling 100 and that affords convenientpassage of sling 100 through tissue of the patient. In a preferredembodiment, sleeve 150 is made of polyethylene. Other materialsincluding, without limitation, polypropylene, nylon, polyester, orTeflon may also be used to construct sleeve 150. Sleeve 150 should alsoconveniently separate from sling 100 after sling 100 is implanted,without materially changing the position or shape of sling 100.

In one embodiment, sleeve 150 may comprise two elongate, separablesections, that substantially form one continuous covering over anchorarms 124, 126 and optionally body 128 and anchors 120, 122. Optionally,portions of two sleeves 150 on opposite arms may detachably andtelescopically overlap near the middle portion of the sling. Optionally,sleeve 150 may be slit or perforated or otherwise breakable (e.g.longitudinally or perpendicular to the longitudinal axis) to affordconvenient separation of the separable sections into separated piecesthat can be removed from a patient after implantation of an anchor.

Optionally, according to various implant embodiments, a material thatforms any portion of a sling 100 may include one or more substancesincorporated into the material or coated onto the material of the sling.Examples of substances may include, without limitation, drugs, hormones,antibiotics, antimicrobial substances, dyes, silicone elastomers,polyurethanes, radiopaque filaments or substances, position or lengthindicators, anti-bacterial substances, chemicals or agents, includingany combinations thereof. A substance or material may be used to enhancetreatment effects, reduce potential sling rejection by the body, reducethe chances of tissue erosion, allow or enhance visualization orlocation monitoring, indicate proper sling orientation, resistinfection, or other provide other desired, useful, or advantageouseffects.

In one embodiment of a method of the invention, an implant such as sling100 (or an anterior portion of another type of implant, e.g., to treatprolapse or a combination of prolapse and incontinence) may beintroduced using an “inside-out” approach to place the implant below theurethra with ends at tissue of the two opposite obturator foramen,through an incision at the vagina or perineum. The precise, finallocation of an implant (e.g., sling 100) will depend on a variety offactors including the particular surgical procedure performed, and anypreconditions of the patient such as scar tissue or previous surgeries.For example, it may be preferred to place an implant such as sling 100in close proximity to, but not in contact with, a mid portion of theurethra to treat incontinence. Alternately, an implant such as sling 100may be placed near the bladder neck. The present invention isparticularly suitable for placing a sling 100 or an anterior portion ofa larger implant that may also treat prolapse, in a therapeuticallyeffective position for treating any one or a combination of pelvicconditions.

For a typical procedure for treating any pelvic condition, a patient maybe first placed under local, spinal, or general anesthesia. According toexemplary methods of treating a female condition of incontinence (e.g.,a small, medial, transvaginal incision for treating female urinaryincontinence) is made in the upper wall of the vagina under themid-urethra. For implantation of a sling 100 to treat incontinence in amale, a perineal incision may be made instead. The incision should belarge enough for the surgeon to place sling 100 through the incisionusing selected instruments. A desired amount of tissue may optionally bedissected on each side, for placement of sling 100. In one embodimentthe tissue may be dissected approximately 1-2 centimeters in eachdirection away from the urethra and toward opposing locations foranchors (or “self-fixating tips”) 120 (e.g., at tissue of the obturatorforamen). The dissection of tissue may be as much or as little asdesired, including none. The first anchor 120 is then placed through theincision and directed toward the desired anchoring position (e.g.,tissue of the obturator foramen).

As previously discussed, a sling 100 or a portion of an implant may bepositioned inside a sleeve 150 before the implant is inserted throughthe incision. In alternate embodiments, sleeve 150 may not be used ornecessary, depending on surgeon preference. In one embodiment, sleeve150 or a delivery tool can cover the woven portion but not anchors 120,122, during implantation. In other embodiments sleeve 150 or a deliverytool may also cover anchors 120, 122. As described herein, embodimentsof the invention can involve the use of various types of delivery toolsto prevent an extension portion of an implant from contacting tissue ofa tissue path during insertion of the extension portion through a tissuepath.

In an exemplary embodiment, anchor 120 can be placed through theincision and into tissue of the obturator foramen (e.g., the obturatorinternus muscle, the obturator membrane, or the obturator externalmuscle). Anchor 120 may be driven to the desired position by thesurgeon's finger or by using an insertion tool such as introducer 160.

Introducer 160 (see FIG. 3A) may be any type of insertion tool that canengage anchor 120 to drive anchor 120 through and into pelvic tissue ofa desired location. Such an introducer 160 may include a durablebiocompatible, curved or straight needle portion 162, made, e.g., ofstainless steel, titanium, Nitinol, polymers, plastics, or otherindividual or combinations of materials. Handle 161 is attached at aproximal end of needle portion 162, and distal end 164 of needle portion162 is designed to engage self-fixating tips 120 and 122, e.g., by beingsized and shaped to fit within an interior channel of each tip 120, 122.Introducer 160 should have sufficient structural integrity to positionanchor 120 as desired. Introducer 160 may mate with or engage anchor 120by any manner, including fitting within an internal channel of a body orbase of anchor 120, alternately on an external portion of a body or baseof an anchor 120, or by interacting with fixation wings 136. Anchor 120,122 may be situated inside or outside of sleeve 150 and introducer 160.

Once a first anchor 120 is placed into a desired position, a secondanchor 122 may be inserted through the same incision and placed in adesired position on an opposite side of the patient. As with the firstanchor 120, the second anchor 122 may be positioned with or without theassistance of an introducer 160 and may be placed, e.g., into tissue ofthe obturator foramen (obturator internus muscle, obturator membrane,obturator externus muscle). Sling body 128 may be properly oriented intothe desired position in relation to the urethra. It may be desirable toensure that the sling 100 is not twisted during implantation.Positioning of implant 100 can be accomplished by selecting the point ofentry and depth of each anchor 120, 122.

FIG. 6 illustrates an example of a therapeutically effective positionfor a uretheral sling such as implant 100 (or, alternately, an anteriorportion of an implant for treating prolapse such as implant 180illustrated in FIG. 3C). Other positions of an implant or sling are alsocontemplated herein, such as positions for treating prolapse, whichcould alternately or additionally place extension portions andself-fixating tips through relatively more posterior tissue pathsleading to posterior tissue of the pelvic region for placement of theself-fixating tips. The precise anatomical position of an implant candepend on a variety of factors including the type and degree ofanatomical damage, location of significant scar tissue, and whether theprocedure is combined with other procedures. Typically, an implant suchas a urethral sling (e.g., sling 100) can be placed mid-urethra, withouttension, but in position to support the mid-urethra. Alternately, thesling could be placed to support the bladder neck and/or UV junction.Implants for use to treat prolapse can be positioned at the middle orposterior vagina, or vaginal vault. Implants for treating fecalincontinence can be placed in the posterior portion of the pelvic regionto support tissue for treating fecal incontinence.

Sling tension may be adjusted by a tension member such as a tensioningsuture disclosed, for example, in U.S. Pat. No. 6,652,450. Thetensioning suture may be constructed from a permanent or absorbable(i.e., bioresorbable or bioabsorbable) material. In still furtherembodiments, an implant such as sling 100 can be introduced with adesired amount of tension in a number of different ways, such as thosediscussed elsewhere in the present description that involve selectedpositioning of self-fixating tips.

A sleeve, 150, if present, may be removed after implantation of animplant such as sling 100 and before the adjustment of tension by atension member such as a tensioning suture. Once the implant ispositioned and optionally tensioned or adjusted, the incision may beclosed.

Another embodiment of the present invention may include a kit thatincludes an implant (e.g., a sling such as sling 100, or any otherimplant as discussed herein), optionally including a sleeve 150, and aninsertion tool such as introducer 160. (See FIG. 3.) The sling 100 mayor may not include bioabsorable portions or portions that induce tissuein-growth. The kit may include one or more insertion tools, which caninclude any features of insertion tools of the present description, andoptionally and preferably can be designed to engage self-fixating tipsof an implant.

As illustrated in FIG. 7, another embodiment of an implant according tothe invention, implant 40, comprising mesh 41, can include anchors 42 inthe form of anchoring fins (or “lateral extensions”) that extenddirectly from locations toward the end of mesh 41. Placing fins 42directly to mesh eliminates a discrete anchor base or anchor body whilestill increasing the anchoring force (pullout force) of a mesh arm. Thefins 42 can be of a design described herein (e.g., of describeddimensions, materials, etc.) to improve pullout force, reduce trauma,allow for a desirable insertion force, etc., and may be moldedseparately and attached directly to the mesh using rivets, ultrasonicwelding, injection molding, or may be woven into the mesh; fins 42 mayalso be attached to a connecting member extending between fins 42 andconnecting to mesh 41, to provide additional support between fins 42 andadditional structural integrity between fins 42 and mesh 42. Fins 42 maybe designed to provide anchoring at a specific anatomical level (on amembrane or fascia, for example) or for anchoring generally into softtissue (muscle or fat).

As illustrated in FIG. 8, another embodiment an implant, andself-fixating tip, can be as shown. Self-fixating tip (anchors) 51 isattached at an end of mesh extension portion 50, by any of a variety ofattachment mechanisms such as by injection molding anchor 51 over anextension portion end. Anchor 51, as illustrated, includes (optional)internal channel 52 for receiving an end of an insertion tool, andmultiple lateral extensions 54 designed to maintain the position ofanchor 51 within tissue. Lateral extensions 54 are in two opposite rowsalong the length of the base of anchor 51, on opposite sides of thebase. Lateral extensions 54 can therefore be placed in an orientationthat is non-parallel to fibers of fibrous tissue such as a muscle of theobturator foramen. To allow placement and positioning of the implant asdesired, anchor 51 can be dimensioned, including its length, to beplaced at a desired depth within a muscle tissue such as, e.g., theobturator internus (the muscle in FIG. 8 is shown in side view toillustrate the depth or thickness dimension of the muscle; the directionof muscle fibers is not illustrated in FIG. 8) or obturator externus.Lateral extensions 54 can also be dimensioned as described herein, toprovide for one or more of desirable insertion force, pullout force, andreduced trauma.

As illustrated in FIG. 9, another embodiment of an implant may includeanchor 60 placed at a distance along a length of an extension portion62, optionally in a manner that allows extension portion 62 to moverelative to anchor 60, e.g., to allow adjustment. In the illustration,anchor 60 has passed completely through the obturator internus muscle(o. int.), punctured the obturator membrane (o. membrane), and has beeninserted within the obturator externus muscle (o. ext.). Anchor 60 maybe placed at a predetermined distance from the end of a mesh extensionportion 62 such that a distal portion of mesh 64 also is located beyondanchor 60. The distal portion of mesh 64 may provide greater initialanchoring and may allow for greater tissue in-growth to occur. Asillustrated, anchor 60 may be a plastic or other biocompatible(optionally bioresorbable) material that is positioned and secured overthe top of extension portion 62. Extension portion 62 passes through abore that extends internally along the longitudinal dimension (length)of anchor 62 and that is sized and shaped such that the position ofanchor 60 can be moveable or secured relative to the extension portion62. Anchor 60 can be positioned and then secured to extension portion62, e.g., by clamping anchor 60 around extension portion 62 or otherwisepassing anchoring arm 62 through the bore until a desired anchorposition is reached and then securing anchor 60 into position relativeto extension portion 62 by use of any desirable and useful securingmechanism. In the embodiment illustrated at FIG. 9, anchor 62 causesmesh of extension portion 62 to reduce in width or narrow as the meshpasses through the internal bore of anchor 60, because of the narrownature of anchor 60. In alternate embodiments, an anchor 62 may be ofthe same or similar dimensions as an extension portion 62 such that themesh does not need to change dimensions as it passes through the bore ofan anchor.

In further embodiments, other instruments, anchors, and insertiondevices, as illustrated herein, may be incorporated or used with devicesand methods of the present description, separately or in anycombination. Various instruments and devices may aid in the insertion orretention of an implant. The devices may also be useful separately orwith alternate methods or implants, as will be appreciated.

FIGS. 10 through 14 illustrate delivery tools for assisting in insertionof an extension portion of an implant. Referring to FIG. 10, deliverytool (or “insertion tool”) 200 includes handle 202 connected to hollowelongate inserter 204. Hollow elongate inserter 204 is an example of aninserter that can be used to insert an extension portion through tissue,with reduced contact between the extension portion and the tissue. Forimplant extensions that do not include a sheath or other removablecovering (e.g., because the sheath can be difficult to remove in theabsence of an external incision, as relates to exemplary methods of thepresent description) an insertion tool such as tool 200 can be used toreduce contact between implant and tissue, during implantation. Elongatehollow inserter 204 includes an elongate slotted tube 207 extending fromhandle 202 to distal end 206. An opening for inserting an implantextension portion, slot 210, extends along the length of tube 207, andalso (optionally, and as illustrated) into handle 202 as slot 212.Internal bore 208 extends the length of tube 207 to form a hollowinterior of tube 207 (bore 208). An extension portion of an implant canbe inserted into slot 210 (and 212), to be contained by tube 207 withinbore 208, for implantation. Tube 207 can act to encapsulate or otherwiseprotect the extension portion as the extension portion is pushed throughtissue (using tool 200). Distal end 206 may be open (as illustrated),closed, or sized to receive a self-fixating tip. For example, distal end206 can engage a self-fixating tip by contacting a complementarysurface, optionally in a desired orientation. Once an extension portionis pushed into tissue of the patient, using tool 200, the extensionportion can be removed from tool 200 by exiting tube 207 through slot210. Tube 207 is shown to be straight, but may optionally be curved asdesired to reach a desired tissue location.

Optionally, another insertion tool such as an elongate needle may beplaced within bore 208. The second tool may include an end that engage aself-fixating tip to push the tip through bore 208 and into tissue ofthe pelvic region. After the self-fixating tip is located within tissueas desired, the second tool may disengage the tip and be removed frombore 208 of tube 207, and tool 200 can be removed from the tissue path.

Referring now to FIG. 11, shown is an end, cross section view ofelongate hollow inserter tool 200 looking in the direction from distalend 206 toward handle 202, FIG. 11 shows tool 200 from this end view,with implant 214 (e.g., mesh extension portion) shown partially withinbore 208 and partially extending out through slot 210. FIG. 11illustrates that a mesh strip (e.g., extension portion, also in an endcross-section view) may be inserted and removed from bore 218 throughslot 210, prior to implanting a mesh strip (e.g., 214) into a tissuepath; once the mesh strip is placed, tool 200 can be removed from themesh strip also by passing the mesh strip (214) through slot 210.

Optionally, a tool such as tool 200, designed to include a hollowinterior for containing an extension portion of an implant, particularlyuseful for implanting an extension portion that does not include aprotective sheath, can additionally include a cover that can open orclose an elongate opening such as slot 210. Referring to FIG. 12A,delivery tool 220 includes an outer slotted tube 222 connected to handle224. An inner slotted tube 226 (see FIGS. 2C and 2D), controlled byhandle 228, is contained concentrically within an internal bore of outerslotted tube 222. Inner slotted tube 226 and outer slotted tube 222 eachincludes handles 228 and 224, respectively. Each slotted tube 222, 226includes an internal bore to produce a hollow interior, and each tubeincludes a longitudinal slot (230, 232, respectively) running the entirelength of each tube 222 and 226. The slotted tubes and internal borescan preferably be concentric to allow slots 230, 232 to be aligned bymanipulation of handles 224 and 228. See FIGS. 12B and 12D, which showthat when slots 230 and 232 are aligned, an extension portion (notshown) can be inserted through both aligned slots, into the internalspace of interior tube 226. As shown in FIG. 12C, slots 230 and 232 canthen be moved relative to each other to close or cover outer slot 230 byrotating the interior tube into position behind outer slot 230.

With further exemplary detail of this insertion tool embodiment, innertube 226 may be sized and shaped such that inner tube 226 is rotatablyenclosed by outer tube 222. As illustrated, inner tube 226 may be longerthan outer tube 222 such that handle 228 of inner tube 226 isaccessible. During placement, an extension portion (e.g., mesh strip)can be enclosed inside of inner tube 226, which is positioned inside ofouter tube 222, and the handles 224 and 228 can be oriented relative toeach other such that slots 230 and 232 are not aligned. See FIG. 12C. Asillustrated, an anchor (self-fixating tip) 234 projects from the distalend of the inner tube 226, but in alternate embodiments inner tube 226may instead enclose an anchor 234 during placement. Once delivery tool220 has been inserted into the desired position, inner tube 226 andouter tube 222 are rotated relative to each other such that slots 230and 232 are aligned and an extension portion contained within inner tube226 can be slid out through aligned slots 230 and 232.

Outer tube 222 and inner tube 226 of tool 220 are shown to be straight,but may be curved if desired, e.g., by selection of a flexible materialfor inner tube 226. Also, a different closing mechanism could be used toclose outer slot 230, such as an inner or outer cover of a smallerdimension relative to the illustrated inner tube 226. For example, FIG.12E shows an example of an outer tube 222 and an inner cover 223, whichis of a reduced size compared to inner tube 226 in terms of arclength.Inner cover 223 functions in a manner similar to inner tube 226, bybeing moveable (according to arrows shown in FIG. 12E) between aposition that covers slot 230 and a position that does not cover slot230 of outer tube 222. Mesh 225 is illustrated also in FIG. 12E.

Another embodiment of an insertion tool (or “delivery tool”) isillustrated at FIG. 13A. This type of tool can also be particularlyuseful to allow delivery of an extension portion of an implant through atissue path to a tissue site, the extension portion not including aprotective sheath, and the tissue path not leading to an externalincision. In general, this type of insertion tool allows delivery at aninternal tissue location, of an extension portion that does not includea sheath, by delivering the extension portion (e.g., inserting aself-fixating tip at internal tissue), then breaking pieces of theinsertion tool away from the extension portion into multiple pieces thatcan be separated from the extension portion and individually removedfrom the patient.

Tool 250 as illustrated in FIG. 13A includes handle 260, elongate body254 extending distally along a length from handle 260. Body 254 includesfirst and second peel lines (or, “separation lines” or “break lines”)258, 259 along a longitudinal length (peel line 259 is shown as dashedline 259 because peel line 259 is located on the far side of body 254).Peel lines 258, 259 may be a tear line or break line, or other separableengagement along which two separate pieces of elongate body 254 cometogether when assembled. Two or more separable pieces 253, 255 of body254 are assembled to allow tool 250 to function during implantation ofan implant, and then can be broken apart or disassembled to remove thepieces after a self-fixating tip has been inserted into pelvic tissue.

As illustrated, two separate pieces (253 and 255) of body 254 are ofsubstantially equal and complementary sizes, i.e., each constitute halfof body 254, to produce a hollow, elongate, cylindrical body from pieces253 and 255 when assembled, with an open interior for locating anextension portion of an implant; illustrated pieces 253, 255, aresubstantially opposite sides (halves) of body 254 that are designedallow body 254 to break apart and separate into two sections along itslength, for removal of separated pieces 253, 255, after implantation ofthe extension portion. Handle 260 can be removed from the proximal endof body 254 to allow pieces 253, 255 to be dis-assembled. Handle 260 maybe integral (as illustrated), or may likewise separate into two pieces.As in the previous delivery tools, body 254, when assembled, includes abore therethrough that encapsulates or encloses an extension portion ofan implant (e.g., a urethral sling) during placement. Moreover, ananchor (252) may or may not extend from a distal end of the body 254during placement. Once delivery tool 250 is in position, handle 260 isseparated into two sections (253, 255) and body 254 is withdrawn andsimultaneously peeled, leaving an extension portion in the desiredposition.

An insertion tool according to the invention can optionally include amechanism by which a self-fixating tip can be securely and releasableengaged with a distal end of an insertion tool such that a self-fixatingtip can be selectively secured to the distal end mechanically, thenreleased; this contrasts with, for example, a simple slidable engagementthat involves only a distal end of an insertion tool engaging a surface(e.g., inner channel) of a self-fixating tip in the absence of anysecuring mechanism. With a releasable engagement, a self-fixating tipcan be removed from the distal end by releasing the engagement (e.g.,mechanical engagement) by movement of an actuator at the proximal end ofthe insertion tool, such as at the handle.

For example, an internal channel (or external surface) of aself-fixating tip base can include an engaging surface designed toengage a mechanism at the distal tip (i.e., distal end) of an insertiontool while the self-fixating tip is placed at, on, or over the distalend of the insertion tool. As an example, an internal or externalsurface of a self-fixating tip can include a depression, ring, edge, orledge, that can be rounded, angular, etc. A mechanical detent such as apin, ball, spring, deflector, or other surface or extension located atthe distal end of the insertion tool can be moved, deflected, orextended relative to the distal end of the insertion tool to contact asurface of the self-fixating tip, such as the depression, ring, edge, orledge, etc., to securely and releasably hold the self-fixating tip atthe distal end of the insertion tool and prevent removal of the tip fromthe distal end, until removal is desired. The detent (extended, moved,or deflected surface, spring, deflector, pin, or ball, etc.) can because to extend from the distal end of the insertion tool by actuating atrigger or other mechanism located at the handle of the insertion tool.Upon placement of the self-fixating tip at a desired location during asurgical implantation procedure, the insertion tool operator can releasethe self-fixating tip by use of the trigger or other mechanism at thehandle to disengage the detent and cause the tip to become loose. Theinsertion tool can then be removed from the tissue path, and theself-fixating tip can remain in a desired implanted location. An exampleof such tool is illustrated that FIGS. 14A, 14B, and 14C.

FIGS. 14A through 14C illustrate a lever-activated delivery tool 270that includes a lever that can activate and de-activate a detent atdistal end 274 of tool 270, the detent being capable of retainingself-fixating tip 272 at distal end 274 during an implantationprocedure, and releasing tip 272 as desired upon placement. Lever 282controls the detent which may be, e.g., a mechanical engagementmechanism that allows delivery tool 270 to securely engage andreleasably dis-engage anchor 272 from distal end 274.

In more detail, tool 270 includes handle 280, having lever 282 operablypositioned (hinged) on handle 280. Elongate hollow tube 276 extendsdistally from handle 280 and includes bore 278 therethrough, from handle280 to distal end 274. Push rod 284 is fitted through bore 278. Anchor272 is fitted into or onto distal end 274 of tube 276. A mesh sling orextension portion (not shown) of an implant can be attached toself-fixating tip 272; an extension portion or mesh sling may beattached directly to anchor 272 such that the extension portion or meshsling drags along the outside of tube 276 during insertion through atissue path. In alternate embodiments a sling or extension portion maybe positioned in a separate bore of tube 276. If anchor 272 is disposedinside of tube 276, a proximal end of the mesh strip or extensionportion can exit the tool at a proximal end of tube 276, or at theproximal side (trigger-side as illustrated) or distal side of handle280.

During insertion, when delivery tool 270 and tip 272 have been placed ina desired position, lever 282 may be moved to cause push rod 284 to movethrough bore 278. At distal end 274, movement of push rod 284 causesrelease of a detent that allows tip 272 to be easily released fromdistal end 274.

Any releasable engagement and detent mechanism that is capable ofholding a self-fixating tip at a distal end of an insertion tool may beuseful according to the present description. As will be appreciated, anumber of different structures, mechanisms, collars, locking arms, orother mechanical features may be integrated into an insertion tool suchas tool 270 to effectuate holding and release of an anchor duringimplantation. A detent or other releasable attachment between a distalend of an insertion tool and a self-fixating tip may operate onprinciples of a friction fit, a snap fit, a twist connection, a rotatingconnection, a moveable engagement, or any other structure of methodknown to those in the mechanical engagement, holding, and release arts.The engagement may contact any portion of a self-fixating tip, such asan internal bore of a base, an external surface of a base, a lateralextension, etc. FIG. 14C shows details of a single embodiment of auseful mechanical detent mechanism; this example is not limiting andother types of engagement mechanisms can be used instead.

Referring now to FIG. 14C, self-fixating tip 272 is located at distalend 274 of tool 270. Self-fixating tip 272 includes internal channel275, base 273, proximal end 290, distal end 292, and lateral extensions294. Distal end 274 of insertion tool 270 includes tube 276, bore 278,and push rod 284. The far distal end of push rod 284 extends to alocation within internal channel 275 of self-fixating tip 272. At thatportion of push rod 285 is connected a collar 286 and an enlarged tip288; in this exemplary illustration, collar 286 can be moveable relativeto pushrod 284, and enlarged tip 288 can be stationary relative topushrod 284.

Within internal channel 275 of self-fixating tip 272, connected tointernal channel 275, are mechanical detents, “arms” or springs 296,biased to contact push rod 285. As will be appreciated, movement ofcollars 286 distally will cause collar 286 to engage springs 296,causing springs 296 to be pushed away from contacting pushrod 285 andcreating an aperture that will allow enlarged tip 288 to be movedproximally through opened springs 296. Collars 286 are moved away frompushrod 285 a sufficient distance to create an opening between springs296 large enough for enlarged tip 288 to pass through the opening whilemoving in a proximal direction, thereby releasing self-fixating tip 272from distal end 274 of the insertion tool.

FIG. 15 illustrates an embodiment of a method of connecting an end ofmesh extension portion 302 to a self-fixating tip 304. Referring to FIG.15, self-fixating tip 304 includes base 306, lateral extensions 308, andinternal channel 310. Ribs 312 are located toward proximal end 314 oftip 306. Ribs 312 are ridges or bumps or extensions on the outer surfaceof tip 306, and (as illustrated) extend around a full circumference ofbase 302. Ribs 312 are not required to be continuous around thecircumference of base 302, but could be intermittent or interrupted.Mesh extension portion 302 contacts proximal end 314 around the exteriorsurface of base 306. According to this embodiment of a self-fixatingtip, ridges 312 allow mesh 302 to be connected to tip 304 by a suture orother mechanical fastening device wrapped around mesh 302, placed aboutbase 306, the suture or fastener being wrapped around base 306 at alocation between ribs 312.

In another embodiment of an implant according to the invention, animplant for treating a pelvic condition such as incontinence, prolapse,or a combined condition of incontinence and prolapse, may be assembledfrom separate pieces, e.g., as a modular assembly of parts, which can beadvantageous for reasons including flexibility in placement of thedifferent pieces and in sizing of an assembled modular implant. FIGS. 16and 17 illustrate implant 320 that includes two support portions 322,each including a self-fixating tip 324 (as described herein). Alsoillustrated is an insertion tool 326 (as described herein) that can beuseful in combination with implant 320, e.g., in the form of a kit.Implant 320 can be placed as two different sections and then connectedtogether at a desired position and tension to form a single implant fromthe combined pieces. Each of the two portions of implant 320 may beplaced with any insertion tool such as tool 326, or any alternateinsertion tool described herein. Once each sling section 322 is placed,sling sections 322 may be attached at their connecting ends 321 by useof any fastening mechanism, such as by clips, sutures, or other methodsknown to those in the art or developed in the future.

FIG. 17 show implant 320 after implantation. Each tip 324 is securedwithin pelvic tissue, such as obturator internus muscle 330, and meshportions 322 extend through tissue paths to meet at connecting ends 321below urethra 328, where connecting ends 321 can be attached togetherwhile a desired amount of tension is placed on urethra 328. Obturatormembrane 332 and obturator externus muscle 334 are also shown.

Another example of a multi-piece, e.g., modular, implant is shown atFIG. 16B. Implant 360 includes two support portions 364, each includinga self-fixating tip 362 (as described herein). Each support portion 364includes a connecting end 366, which includes a non-perpendicular cut,such as a slanted cut (as illustrated). The use of a non-perpendicular(e.g., slanted) cut can result in a reduced amount of overlappingmaterial underneath a urethra upon implantation of portions 364 andconnection together of connecting ends 366. A reduced amount of implantmaterial (e.g., mesh) present below the urethra can reduce the bulk ofthe supportive material below the urethra and can reduce the chance oferosion. Implant 360 can be placed as two different sections and thenconnected together at a desired position and tension to form a singleimplant from combined portions 364. Once each sling portion 364 isplaced, sling portions 364 may be attached at their connecting ends 366by use of any fastening mechanism, such as by clips, sutures, or othermethods known to those in the art or developed in the future.

Another example of a multi-piece, e.g., modular, implant is shown atFIG. 16C. Implant 370 includes two support portions 378, each includinga self-fixating tip 372 (as described herein). Each support portion 378includes a proximal portion 376 and distal portion 374. Proximal portion376 is the portion of the implant material that will be located belowthe urethra upon implantation, and distal portion 374 connects proximalportion 376 to self-fixating tip 372. According to this embodiment ofthe invention, proximal portion 376 is made of support material that isof a density (mass per volume) that is less than the density of distalportion 374. The use of a reduced density material for proximal portions376, which can be connected below the urethra, cut can result in areduced amount of overlapping material underneath a urethra uponimplantation of portions 378 and connection together of proximalportions 376. A reduced amount of implant material (e.g., mesh) presentbelow the urethra can reduce the bulk of the supportive material belowthe urethra and can reduce the chance of erosion. Implant 370 can beplaced as two different sections and then connected together at adesired position and tension to form a single implant from combinedportions 378. Once each sling portion 378 is placed, sling portions 378may be attached at their proximal portions 376 by use of any fasteningmechanism, such as by clips, sutures, or other methods known to those inthe art or developed in the future.

In a further embodiment of an implant shown at FIG. 18, an implant mayinclude an anchor 340, mesh extension portion 344, and break-awayplastic sheath 346. Perforations 348 are located on sheath 346 at aposition near anchor 340. A breakable connection such as perforations348 allows sheath 346 to be removed, e.g., broken or torn away from, theperforated connection near anchor 340 after anchor 340 is implanted intopelvic tissue. The size and amount of perforations 348 can be selectedto cause sheath 346 to break at perforations 348 instead of movinganchor 340 when sheath 346 is pulled.

Alternately or in addition to perforations 348, an elongate wire,needle, string, or other connection (not shown), can extend from thelocation of perforations 348 to a location available to a physicianduring implantation, so that the connection can cause sheath 346 to bebroken near anchor 340 as desired. According to one specific example ofthis design, a needle with bend or a T-shaped tip may be situated withinsheath 346 and positioned next to a perforated or otherwise weakenedsection of the sheath, e.g., near self-fixating tip 340. When anchor 340has been implanted at a desired position within tissue, the needle maybe spun, turned, or otherwise moved or manipulated to break sheath 346at a location near anchor 340 and release sheath 346 from anchor 340. Infurther embodiments the needle and sheath 346 may be integrally formedso that when the needle is twisted or pulled, the end of 346 sheathtwists relative to anchor 340 and the torque force breaks sheath 346near anchor 340.

Embodiments of implants can also allow for adjusting the position ortension of an implant after implantation. An example is shown at FIG.19. Urethral sling 350 includes anchors 352 and 353 placed at opposingobturator internus muscles 354. Obturator membrane 356 and obturatorexternus muscle 358 are also shown. Implant 350 can be affixed usingfirst anchor 352, which is fixed to one end of implant 350, and isadjustably attached to anchor 353 on the other end. Anchors 352 and 353may be self-fixating tips as described. However, anchor 353 includes aloop or slot 355 through which end 351 of implant 350 can be adjustablylocated, then secured into place upon positioning or adjustment. Implantend 351 is passed through aperture 355 of anchor 353 and is drawn backalong a tissue insertion path to achieve desired positioning andtensioning of implant 350 relative to urethra 360. When the desiredamount of tension is achieved on implant 350, or supportive force onurethra 360, end 351 of implant 350, drawn through aperture 355, may befastened or otherwise coupled or locked by a clip, or by any othermeans, to implant 350, to secure the position of implant 350.

Another example of a useful self-fixating tip according to the presentdescription, is illustrated at FIGS. 20A through 20D. Self-fixating tip400 includes base 402, proximal base end 406, distal base end 408, andinternal channel 404. Extending from base 402 are lateral extensions410, which extend laterally and in a direction that includes a componenttoward proximal base end 406. Lateral extensions 410 can be sufficientlyrigid to be fixed, to not deflect upon insertion through tissue, or maybe capable of deflecting in a proximal direction if desired. Lateralextensions 410 are shown to exhibit a thickness that slightly less thana thickness of base 402 (i.e., a thickness at proximal base end 406),but the thickness of lateral extensions 410 could also be the same asthe thickness of based 402. As shown at FIGS. 20C and 20D, distal baseend 408 includes a curve.

An alternate embodiment of an implant portion is illustrated at FIGS.21A and 21B. Implant portion 420 includes mesh 422 and self-fixating tip424 (including one or more features as described herein), contained byhollow elongate inserter 430. Self-fixating tip 424 includes moveablesection 428, and two optional sutures 426, one attached to each moveablesection 428. During use, self-fixating tip 424 can be inserted intopelvic tissue 432, as shown at FIG. 21B. Inserter 430 can be withdrawn.Optionally, moveable sections 428 can be biased to extend away from eachother, optionally away from a base of self-fixating tip 424, uponremoval of inserter 430. Alternately, or in addition, optional sutures426 can be pulled to cause moveable sections 428 to move laterally andaway from each other, optionally away from a base of self-fixating tip424, to extend into tissue 432 and secure self-fixating tip withintissue 432.

Another alternate embodiment of an implant portion is illustrated atFIGS. 22A and 22B. Implant portion 400 includes mesh 442 andself-fixating tip 448 (including one or more features as describedherein). Inserter tool 444 is shown in a position engaging self-fixatingtip 448. Self-fixating tip 448 includes three moveable sections 450,each section including three lateral extensions 452. During use,self-fixating tip 448 can be inserted into pelvic tissue and moveablesections 450 can be expanded to increase the size of self-fixating tip448 within the tissue. Optionally, moveable sections 450 can be biasedto extend away from each other, e.g., upon removal of an inserter (notshown). Alternately, or in addition, moveable sections 450 can be causeto extend laterally away from each other, as desired, such a by use of apush-rod or other mechanism (not shown) contained by inserter tool 444,that can be actuated from a proximal end of the inserter tool.

Another alternate embodiment of an implant portion is illustrated atFIGS. 23A and 23B. Implant portion 460 includes mesh 462, plasticprotective sheath 464, and self-fixating tip 468 (including one or morefeatures as described herein, including lateral extensions 470). Tool472 is shown in a position that places a “T” end at a location nearself-fixating tip 468; an opposite end of tool 472 is located at aposition that is accessible to a physician during an implantationprocedure. During use, self-fixating tip 468 can be inserted into pelvictissue as described herein. Tool 472 can be twisted, turned, or moved,or removed from the location with “T” near self-fixating tip 468, andsuch movement will cause sheath 464 to tear, break, or otherwiseseparate, at a location near self-fixating tip 468, so that sheath 464can be removed.

Although embodiments of the present invention have been described withreference to the treatment of female urinary continence, it should beappreciated that many of these embodiments would also be suitable torepair a variety of pelvic conditions in both males and females. Forexample, embodiments of the present invention would be suitable for avariety of pelvic floor repairs and/or treatments, including pelvicorgan prolapse repair, levator hiatus repair, fecal incontinencetreatment, perineal body support and hysterectomy support.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

The invention claimed is:
 1. A pelvic implant assembly comprising: asupport portion; a first mesh extension portion extending from thesupport portion; and a second mesh extension portion extending from thesupport portion; a first self-fixating tip directly connected to thefirst mesh extension portion, the first self-fixating tip including abase having a proximal base end, a distal base end, and a length betweenthe proximal base end and the distal base end defining a longitudinalaxis, the proximal base end configured to be coupled to the first meshextension portion, the base including an internal channel extending fromthe proximal base end to the distal base end, the base including a firstlateral fin extending from the base in a first direction, and a secondlateral fin extending from the base in a second direction, the firstlateral fin has a first length dimension, where the first lateral finmeets the base, and a second length dimension, opposite the first lengthdimension, where the first lateral fin extends away from the base, thefirst length dimension being larger than the second length dimension,and each of the first length dimension and the second length dimensionextending in a direction parallel to the longitudinal axis; and a secondself-fixating tip directly connected to the second mesh extensionportion.
 2. The pelvic implant assembly according to claim 1, whereinthe first lateral fin includes a leading edge that extends away from afirst location on the base and extends proximally to a point, and thefirst lateral fin includes a trailing edge that extends away from asecond location on the base to the point.
 3. The pelvic implant assemblyaccording to claim 2, wherein the leading edge includes a sharpenededge.
 4. The pelvic implant assembly according to claim 2, wherein thetrailing edge includes a portion having a thickness in a range from 0.2to 1.5 millimeters.
 5. The pelvic implant assembly according to claim 1,wherein the first lateral fin includes a width dimension in a range from0.5 to 3 millimeters, and a thickness dimension in a range from 0.2 to1.5 millimeter.
 6. The pelvic implant assembly according to claim 1,wherein the first length dimension of the first lateral fin is in arange from 0.5 to 5 millimeters.
 7. The pelvic implant assemblyaccording to claim 1, wherein the first length dimension of the firstlateral fin is in a range from 1 to 4 millimeters.
 8. The pelvic implantassembly according to claim 1, wherein a length of the first meshextension portion is adjustable.
 9. The pelvic implant assemblyaccording to claim 1, wherein the length between the proximal base endand the distal base end is in a range from 0.4-1.0 centimeter.
 10. Amedical apparatus comprising: a pelvic implant including a supportportion, a mesh extension portion extending from the support portion,and a self-fixating tip directly connected to the mesh extensionportion, the self-fixating tip including a base having a proximal baseend and a distal base end, the proximal base end configured to becoupled to the mesh extension portion, the base including an internalchannel extending from the proximal base end to the distal base end, theinternal channel includes a flat surface, the base including a firstlateral fin extending from the base in a first direction, and a secondlateral fin extending from the base in a second direction; and aninsertion tool having a handle and a needle extending from the handle,the needle including a proximal end attached to the handle and a distalend, the distal end including a tip configured to engage theself-fixating tip, the tip having a diameter that is smaller than adiameter of a shaft of the needle, the needle including an exteriorsurface that is configured to engage the flat surface of the internalchannel of the base.
 11. The medical apparatus of claim 10, wherein theneedle includes a curved needle portion, the self-fixating tip maintainsan orientation relative to the insertion tool with the first lateral finand the second lateral fin aligned for implantation into fibrous tissuethe first lateral fin and the second lateral fin configured to penetratethe fibrous tissue in an orientation that is non-parallel to a directionof fibers of the fibrous tissue.
 12. The medical apparatus of claim 11,wherein the self-fixating tip maintains an orientation relative to theinsertion tool in which the first lateral fin and the second lateral finare aligned at an angle in a range from 70 to 100 degrees relative tofibers of obturator internus muscle tissue.
 13. A method of treating apelvic condition, the method comprising: providing the medical apparatusof claim 10; engaging the distal end of the needle with theself-fixating tip in a manner that allows the needle to push theself-fixating tip into tissue; inserting the distal end of the needleand the self-fixating tip through a perineal or vaginal incision in apatient; and using the needle to push the self-fixating tip to insertthe self-fixating tip into the tissue in the pelvic region.
 14. Themethod of claim 13, wherein the pelvic condition is selected from thegroup consisting of: urinary incontinence, fecal incontinence,enterocele, cystocele, rectocele, and vaginal vault prolapse.
 15. Themethod of claim 13, wherein the incision is selected from a vaginalincision of a female patient and a perineal incision of a male patient.16. The method according to claim 13, wherein the method includesplacing the self-fixating tip in fibrous tissue, with the first lateralfin and the second lateral fin of the self-fixating tip being orientedin a direction that is non-parallel to fibers of the fibrous tissue. 17.The method according to claim 13, wherein the method includes insertingthe self-fixating tip into fibrous tissue with the first lateral fin andthe second lateral fin aligned at an angle in a range from 70 to 100degrees relative to fibers of the fibrous tissue.
 18. The medicalapparatus according to claim 10, wherein the implant includes a meshstrip and two self-fixating tips, one self-fixating tip at each end ofthe mesh strip.
 19. The medical apparatus according to claim 10, whereinthe implant includes a tissue support portion, two posterior extensionportions, the self-fixating tip being disposed at a distal end of eachposterior extension portion, and with the tissue support portion placedat posterior vaginal tissue, the self-fixating tip configured to beplaced at tissue of the sacrospinous ligament.
 20. The medical apparatusaccording to claim 10, wherein the first lateral fin includes a leadingedge and a trailing edge, the leading edge extending away from a firstlocation on the base and extending proximally to a point, the trailingedge extending away from a second location on the base to the point. 21.The medical apparatus according to claim 20, wherein the leading edgeincludes a sharpened edge.